2015 Clinical Update - Choose Your Region - Endologix · Endologix, Inc. Powerlink System and AFX...

2 Musick │ Irvine, CA 92618 │ Tel 949.595.7200 │ Fax 949.612.1893 │ www.endologix.com

2015 Clinical Update Endovascular Systems for AAA Repair

Endologix, Inc. Powerlink System and AFX Endovascular AAA System 2015 Clinical Update

MM1059 Rev 01 2

TABLE OF CONTENTS

Section Page

ABSTRACT ........................................................................................................................................ 3

READER’S GUIDE............................................................................................................................... 4

SECTION 1: US PIVOTAL CLINICAL STUDIES ........................................................................................... 8

Patient Status and Accountability ............................................................................................ 9

Aneurysm-Related Mortality ................................................................................................. 14

All-Cause Mortality ................................................................................................................ 16

Major Adverse Events ............................................................................................................ 17

Treatment Effectiveness ........................................................................................................ 22

Aneurysm Sac Exclusion ............................................................................................ 22

Migration ................................................................................................................. 22

Endoleak Incidence ................................................................................................... 23

Secondary Interventions ............................................................................................ 24

Device Integrity......................................................................................................... 25

Summary .............................................................................................................................. 26

Future Plans .............................................................................................................. 26

SECTION 2: COMMERCIAL EXPERIENCE ............................................................................................ 27

Aneurysm-Related Mortality and Surgical Conversion ........................................................... 27

Aneurysm Rupture Post-Procedure ........................................................................................ 29

Endoleak ............................................................................................................................... 29

Device Integrity ..................................................................................................................... 29

Commercial Experience Summary .......................................................................................... 30

SECTION 3: DEVICE EXPLANT EVALUATIONS ...................................................................................... 31

SECTION 4: NOTES TO CLINICIANS ................................................................................................... 32

SECTION 5: BRIEF SUMMARY OF INDICATIONS, WARNINGS AND PRECAUTIONS FROM IFU ............... 37


MM1059 Rev 01 3

ABSTRACT

This 2015 Clinical Update report provides a current summary of long-term clinical experience for the Endologix

studies for endovascular abdominal aortic aneurysm (AAA) repair with the Endologix Powerlink and AFX stent

graft systems. Five US clinical studies involving 726 patients have been performed and results submitted

to the US FDA to support marketing approvals. This includes the Infrarenal Bifurcated study, Suprarenal

Bifurcated study, XL Aortic Extension study, Suprarenal Aortic Extension study, and the PEVAR Trial. In

addition, post-marketing information is included regarding worldwide commercial experience, trends, and

new or improved devices since the original FDA approval.

In the five-year follow-up of the Bifurcated studies, both test and open surgical control patients were

evaluated. Primary endpoint follow-up for patients enrolled in all five studies was completed and approved by

the US FDA. The Kaplan-Meier five-year estimates in the Infrarenal Test, Suprarenal Test, and Surgical Control

groups, respectively, are: 98%, 98%, and 94% (freedom from aneurysm-related mortality); 77%, 77%, and 73%

(freedom from all-cause mortality); and 47%, 53%, and 58% (freedom from major adverse events). The XL and

Suprarenal aortic extension devices were approved based upon pivotal study endpoint results of the

prospective multi-center studies in which all patients received the bifurcated device via anatomical fixation at

the aortoiliac bifurcation, and either the XL aortic extension or suprarenal aortic extension placed proximally

to achieve seal. At one year, freedom from aneurysm-related mortality, conversion to open repair, and

migration in both studies was 100%. Five-year follow-up for patients enrolled in the XL and Suprarenal Aortic

Extension studies is complete. The PEVAR Trial is the first multicenter, prospective, randomized trial of

percutaneous endovascular aneurysm repair, and used the Endologix stent graft device for the endovascular

repair. Femoral artery access was obtained using totally percutaneous techniques with suture-mediated

closure devices, or using standard femoral exposure. The 1-month Treatment Success primary endpoint results

of this trial demonstrated non-inferiority of PEVAR (facilitated with the Abbott Vascular, Inc. ProGlide device)

in comparison to EVAR with standard femoral exposure. Final six-month follow-up for patients enrolled in the

PEVAR Trial is complete.

In summary, Core Laboratory evaluations of CT scans and x-rays have revealed no aneurysm rupture, stent

fracture, or graft holes in any subject enrolled in the clinical studies of AAA repair with the Endologix Stent

Graft Systems. Limited device migration has been observed, and endoleaks have been primarily identified as

Type II, with a low incidence of Type I proximal or distal endoleak. Among all test patients who received the

bifurcated device, 100% freedom from aneurysm-related mortality is observed. Moreover, a progressive

reduction in mean aneurysm sac diameter is observed at each completed follow-up interval, with the large

majority of patients exhibiting a significantly decreased or stable aneurysm size.

The commercial experience related to aneurysm-related mortality among intraoperative and postoperative

reports observed globally (more than 151,000 devices distributed) is consistent with the controlled clinical

study experience. Improvements have been made to the delivery system to mitigate potential risks and to

proactively respond to customer feedback. In mid-2011, Endologix introduced the AFX® Endovascular AAA

System which integrates a low profile, hydrophilically-coated 17Fr introducer system with AFX delivery

systems, standard 9Fr percutaneous, pre-cannulated contralateral access, and stent grafts ranging in diameter

from 22 to 34mm proximally and 13 to 25mm distally featuring proprietary ePTFE graft technology. Additional

improvements include the Vela™ Proximal Endograft System with radiopaque marker and improved delivery

control and introduction of Duraply™ graft material with enhanced strength properties, both introduced in

2014.


MM1059 Rev 01 4

READER’S GUIDE Endologix, Inc. has prepared this clinical update to provide current information on the worldwide experience

to date to physician users. Data and information on the final follow-up on the test patients implanted with

the device during the original studies and on surgical control patients is detailed, including patient

accountability, adverse events, incidence of endoleak, and aneurysm sac diameter regression. In addition,

worldwide post-market information pertaining to product use, safety, and performance are discussed. A brief

summary of the stent graft and delivery system design and construction as well as the regulatory status is

provided below. The remainder of this section provides an overview of the contents of this report.

Device Description The Endologix Powerlink and AFX stent graft systems are indicated for the endovascular treatment of

abdominal aortic aneurysm (AAA) using a surgical vascular access technique or a bilateral percutaneous

technique in patients having suitable anatomy, including an adequate proximal aortic neck seal zone and

common iliac artery seal zones. When deployed across the aortic aneurysm, the self-expanded stent graft

implant provides a permanent conduit for blood flow, excluding the aneurysm sac from blood flow and

pressurization. Refer to the Instructions for Use for all indications, contraindications, warnings, precautions,

and details for proper use of the device.

In recent years, Endologix has made several important improvements to the AFX stent graft family:

1. The Vela™ Proximal Endograft System was introduced for suprarenal and infrarenal proximal stent graft

devices in February 2014. The stent graft was improved with the addition of a radiopaque marker within

the proximal edge of the stent graft; this enhances fluoroscopic visualization during placement of the

graft-covered device below the most caudal renal artery. The delivery system was improved with the

addition of an internal constraining sleeve and refinements to the deployment mechanism, which enable

further physician control over the stent graft deployment process to aid in precise placement at the

desired location.

2. A change to the expanded polytetrafluoroethylene (ePTFE) graft processing methods was introduced in

October 2014 which results in an ultra-high-density, multi-layered material referred to as Duraply™. This

improvement increased the graft material strength unilaterally while preserving the material’s

biocompatibility profile, and all other conformability and mechanical characteristics.

3. AFX Instructions for Use (IFU) were updated in 2015 to further clarify existing information related to

procedure planning and follow-up imaging, and to improve the instructions for Vela deployment and

delivery system withdrawal. Updates focused mainly on factors related to Type III endoleak prevention

and monitoring; strengthening warnings/precautions, clarifying patient selection/treatment approach,

and recommendations for imaging and post-operative patient follow-up. The imaging guidelines section

was updated to include factors specific to Type III endoleak identification, including reduction in overlap

and device integrity verification.

4. The AFX2 Bifurcated Endograft System is FDA and CE Mark approved. AFX2 consists of a new delivery

system that features an integrated 0.035” contralateral wire to replace the previous 0.014” wire,

refinement of the hemostatic control within the handle, and reduction of the contralateral introducer

from 9F to a 7F profile. The inclusion of a contralateral .035" wire eliminates the previous contralateral

wire exchange reducing both the number and complexity of steps in deployment. AFX2 is expected to

be introduced in the U.S. and international markets in 2016.


MM1059 Rev 01 5

The Endologix unibody infrarenal bifurcated stent grafts (primary device) has a main body with two attached

limbs. Accessory stent grafts for customization to the patient anatomy are comprised of infrarenal and

suprarenal proximal extensions and limb extensions in straight, tapered, flared, and stepped configurations.

Both Powerlink and AFX stent grafts are constructed from the same cobalt chromium alloy stent cage. The

high density expanded polytetrafluoroethylene (ePTFE) graft cover used in the AFX stent graft evolved from a

process improvement which reduced the Powerlink ePTFE graft material thickness by half while maintaining

the same mechanical strength and durability specifications to allow for a reduction delivery system profile.

Surgical suture attaches the bifurcated body and limb grafts, and attaches the graft to the stent at each end.

In the suprarenal configuration, a 2cm-length bare stent segment is attached to the proximal end of the stent

graft. The bifurcated and proximal extension stent graft configurations are depicted in Figure 1. The limb

extension stent graft configurations are shown in Figure 2.

Figure 1. Bifurcated and Proximal Extension Stent Graft Configurations

Infrarenal Bifurcated Stent Graft Infrarenal Proximal Extension Stent Graft

Suprarenal Proximal Extension Stent Graft

Figure 2. Limb Extension Stent Graft Configurations

Straight and Tapered Limb Extension Stent Grafts Flared and Stepped Limb Extension Stent Grafts

Placement of the long main body of the bifurcated stent graft with attached limbs at the aortoiliac

bifurcation serves as the foundation for the implant by providing columnar support in the aneurysm sac,

directly absorbing the luminal blood flow at the natural anatomical bifurcation, and eliminating the

need for stent graft fixation within the proximal neck. The proximal extension and limb extension stent

grafts permit customization of the implant to the patient anatomy as required, accommodating a range of

proximal neck and iliac diameters.


MM1059 Rev 01 6

The AFX® Endograft AAA System is used with a separate 17Fr AFX Introducer System (19Fr outside diameter).

All AFX stent graft delivery systems are compatible with the AFX Introducer System. There are three types of

stent graft delivery systems that require delivery through the introducer system: the bifurcated stent graft

delivery system; the Vela™ Proximal Endograft System, and the standard limb extension delivery system. A

lower profile limb extension delivery system in 14 or 16Fr outer profile may be used alone or in conjunction

with the introducer system. Only one femoral access site compatible with the 17Fr introducer sheath is

required for ipsilateral deployment; contralateral access is compatible with standard percutaneous 9Fr

introducers for the current AFX Bifurcated Endograft delivery system and reduces to 7Fr with the forthcoming

AFX2 Bifurcated Endograft System.

Introduction Endologix is dedicated to putting patients first in all we do. Central to this core value is our commitment to provide updated and emerging data and information to the physicians who care for these patients on our products and their safety and performance profiles. This 2015 annual update marks the 11-year anniversary of the initial US Food and Drug Administration (FDA) premarket approval of our Powerlink System, which is also available internationally in various countries. The AFX System has been available in the US since FDA approval in 2011. It was introduced in Europe shortly after the US introduction, and is available internationally in various countries. The results contained in this report indicate that the Powerlink and AFX Systems provide a safe and effective endovascular aneurysm repair (EVAR) stent graft option in appropriately selected patients. Section 1 presents the long-term, final follow-up results from the five US pivotal clinical studies conducted

with the Powerlink stent graft: the Infrarenal Bifurcated study, Suprarenal Bifurcated study, and XL study

(34mm proximal extension), Suprarenal Extension study, and PEVAR (totally percutaneous EVAR) Trial. Safety

results presented include the incidence of major adverse events as prospectively defined in the study

protocols. Kaplan-Meier estimates for freedom from major adverse events, freedom from all-cause mortality,

and freedom from aneurysm-related mortality are also presented. Effectiveness results include primary

performance measures, and Core Laboratory reported aneurysm morphology evaluations, migration, endoleak

incidence, secondary interventions, and stent graft performance measures including device patency, stent

fracture, and graft integrity. Early, mid- and long-term follow-up results from the studies are positive.

Moreover, results are consistent between studies, providing additional validating evidence as to the

conclusions that can be drawn from the study results.

In the Infrarenal and Suprarenal Bifurcated studies, results within one year demonstrate reduced incidence of

major adverse events compared to the surgical control group. Continued follow-up through five years finds

no significant differences between groups. Among all test patients, no aneurysm rupture was observed.

Kaplan-Meier estimates for Infrarenal and Suprarenal test patients, respectively, include freedom from

major adverse events (47%, 53%); freedom from all-cause mortality (77%, 77%); and freedom from aneurysm-

related mortality (98%, 98%). Aneurysm size is stable or decreased in the majority of patients, and mean sac

diameter continued to decrease over time in the test groups. Secondary interventions within five years were

performed primarily for Type II endoleak, with low rates of device-related interventions for endoleak or limb

occlusion. No aneurysm rupture, stent fracture, graft failure, or other significant device integrity loss was

observed through the five-year follow-up.

No aneurysm-related mortality was observed in the XL and suprarenal aortic extension studies, which

prospectively studied the anatomical fixation algorithm of the Endologix endografts. Unique to our platform,

the bifurcated device with long main body was placed at the aortoiliac bifurcation with the long main body

across the aneurysm; a proximal extension of suitable diameter was then placed to achieve both significant

overlap with the bifurcated device body and proximal seal in the infrarenal neck. Aneurysm size is stable or


MM1059 Rev 01 7

decreased in the majority of patients, and mean sac diameter continued to decrease over time. Secondary

interventions within five years were performed primarily for Type II endoleak, with low rates of device-related

interventions for endoleak or limb occlusion. No aneurysm rupture, stent fracture, graft failure, or other

significant device integrity loss was observed through final five-year follow-up.

No aneurysm-related deaths were observed in the PEVAR trial among 100 patients randomized to either totally percutaneous access or standard femoral exposure and endovascular repair using the Powerlink endografts. Treatment Success at one month, defined as procedural technical success per randomized assignment and absence of major adverse event or vascular event, was 88% and 78% in the PEVAR/ProGlide and SEVAR groups, respectively. No aneurysm rupture, stent fracture, graft failure, or other significant device integrity loss was observed through final six month follow-up.

Section 2 presents the worldwide post-marketing experience. A total of 151,652 devices have been distributed

globally since initial marketing. Endologix maintains an active system for collection, monitoring, and handling

of customer experience reports (complaints) for its devices marketed worldwide. Integral to this system is

the reporting of events in accordance with US regulations under 21 CFR 803 (Medical Device Reporting)

and international Vigilance reporting requirements. Post-market surveillance has served to verify the

effectiveness of the training program, and provided confirmation of elements of the approved labeling

intended to mitigate risks. Such elements include:

Identification and selection of suitable patient anatomy;

Proper aneurysm and vascular sizing based on a recent high-resolution, contrast-enhanced computed

tomography (CT) scan;

Proper stent graft selection and placement for the vascular and aneurysm anatomy being treated;

Use and maintenance of a stiff guidewire during device delivery and deployment;

Identification and use of radiopaque markers during placement, deployment, and delivery system

removal.

Section 3 provides a summary of all explant analyses from the pivotal clinical studies, as well as from

commercial experience. Analyses included evaluation of the explanted stent graft using s tanda rd

tech ni ques . Histopathological analyses were conducted by an independent, qualified laboratory.

Section 4 provides Notes to Clinicians on the AFX System, and discusses important information on patient

selection, device selection, and patient follow-up recommendations, including imaging assessments.

Section 5 provides a brief summary of the product indications, contraindications, warnings, and precautions;

it also provides information on the peer-reviewed published literature of Powerlink and AFX outcomes to

further inform physician decision making in caring for patients with AAA.


MM1059 Rev 01 8

SECTION 1: US Pivotal Clinical Trials Endologix has completed five US pivotal clinical studies of the Powerlink System for endovascular AAA repair that were the basis for determinations of reasonable assurances of safety and effectiveness by the US Food

and Drug Administration:†

• Infrarenal Bifurcated Study: This multicenter, prospective, concurrently controlled clinical study

compared 192 standard risk patients with anatomy suitable for endovascular repair to 66 patients

treated with open surgery. Patients were enrolled between July 2000 and March 2003, and per the

originally approved protocol and patient consent, were followed to the primary one year timepoint

with continued long-term follow-up commitment. An independent data safety monitoring board (DSMB)

reviewed the results of this study and recommended study continuation. Clinical and imaging follow-

up were obtained pre-discharge, 30 days, six months, one year, and annually thereafter to five years.

Imaging (CT scans and x-rays) results were evaluated by a central Core Laboratory (M2S, Inc., West

Lebanon, NH) to ensure consistency in stent graft integrity, endoleak and migration assessments as well

as aneurysm morphology improvements. These results were submitted to the US FDA, with initial

approval of the premarket approval application (PMA) in October 2004. The complete five-year follow-

up study report was submitted to and approved by the US FDA in 2009.

• Suprarenal Bifurcated Study: This multicenter, prospective, historically controlled clinical study

compared 153 standard risk patients with anatomy suitable for endovascular repair to the 66 patients

treated with open surgery (described above). Patient enrollment commenced in October 2001, and

per the originally approved protocol and patient consent, patients were followed to the primary

one year timepoint with continued long-term follow-up commitment. An independent DSMB

periodically reviewed the results of this study and recommended study continuation in each review.

Clinical and imaging follow-up were obtained pre-discharge, 30 days, six months, one year, and at

yearly intervals thereafter. Imaging (CT scans and x-rays) results were evaluated by the central Core

Laboratory (M2S, Inc.) to ensure consistency in stent graft integrity, endoleak and migration

assessments as well as aneurysm morphology improvements. These results were submitted to the US

FDA, with approval of the PMA supplement in October 2008. Final five-year follow-up is complete.

• XL Study: This multicenter, prospective, single arm clinical study enrolled 60 patients with wide infrarenal

aortic necks (up to 32mm in diameter) and anatomy suitable for endovascular repair. Enrollment

commenced in September 2005, and per the originally approved protocol and patient consent, patients

were followed to the primary one-year time point with continued long-term follow-up commitment. An

independent DSMB periodically reviewed the results of this study and recommended study continuation

in each review. Clinical and imaging follow-up were obtained pre-discharge, 30 days, six months and

at yearly intervals. Imaging (CT scans and x-rays) results were evaluated by the central Core

Laboratory (M2S, Inc.) to ensure consistency in stent graft integrity, endoleak and migration

assessments as well as aneurysm morphology improvements. These results were submitted to the

US FDA, with approval of the PMA supplement in November 2008. Final five-year follow-up is complete.

†Please refer to the approved Summary of Safety and Effectiveness Data under P040002: Infrarenal Bifurcated Study (original); Suprarenal Bifurcated Study (S018); XL Aortic Extension Study (S019); Suprarenal Aortic Extension Study (S022); PEVAR Trial (S039).


MM1059 Rev 01 9

• Suprarenal Aortic Extension Study: This multicenter, prospective, single arm clinical study enrolled

44 patients with infrarenal aortic necks up to 26mm in diameter and anatomy suitable for endovascular

repair. Enrollment commenced in May 2006, and per the originally approved protocol and patient

consent, patients were followed to the primary 30-day time point with continued long-term follow-up

commitment. An independent DSMB periodically reviewed the results of this study and recommended

study continuation in each review. Clinical and imaging follow-up were obtained pre-discharge, 30 days,

six months and at yearly intervals. Imaging (CT scans and x-rays) results were evaluated by the central

Core Laboratory (M2S, Inc.) to ensure consistency in stent graft integrity, endoleak and migration

assessments as well as aneurysm morphology improvements. These results were submitted to the US

FDA, with approval of the PMA supplement in April 2009. Final five-year follow-up is complete.

• PEVAR Trial: This multicenter, prospective, randomized clinical trial enrolled 100 randomized patients

(1:1, PEVAR: SEVAR) with anatomy suitable for endovascular repair using the Endologix stent graft

system. Randomized trial enrollment commenced in July 2010, and per the originally approved protocol

and patient consent, patients were followed to the primary 30-day time point and final 6-month

timepoint. An independent DSMB periodically reviewed the results of this study and recommended study

continuation. Clinical and imaging follow-up were obtained pre-discharge, 30 days, and at six months.

Imaging (CT scan and femoral ultrasound) results were evaluated by an independent assessor and clinical

events committee to identify and adjudicate adverse events. These results were submitted to the US

FDA, with approval of the PMA supplement in April 2013. Final six-month follow-up is complete.

Final safety and effectiveness results are included in this section for each study. Patient Status and Accountability

As detailed in the approved labeling, Infrarenal and Suprarenal test and control patients were shown to be

demographically similar, except that test patients from both studies were significantly older than control

patients, and Suprarenal test patients had a significantly increased history of arrhythmia.

Patient status and accountability from the time of enrollment through final follow-up are presented in

Table 1 (Infrarenal Bifurcated Test Group); Table 2 (Infrarenal Bifurcated Control Groups); Table 3 (Suprarenal

Bifurcated Test Group); Table 4 (XL Aortic Extension Test Group); Table 5 (Suprarenal Aortic Extension Test

Group) and Table 6 (PEVAR Trial allocated groups).


MM1059 Rev 01 10

Table 1. Patient and Imaging Accountability – Infrarenal Bifurcated Study Test Group1

Interval

Patient Follow-up

n (% of eligible)

Pts. with Imaging

n (% of eligible)

Pts. with Adequate Imaging to Assess

Parameter -- n (% of eligible)

Events Occurring Before

Next Visit

Elig

ible

Clin

ical

Follo

w-u

p

Imag

ing

Follo

w-u

p

CT

Scan

Du

ple

x

Ult

raso

un

d

KU

B Im

agin

g

An

eu

rysm

Size

An

eu

rysm

Size

Ch

ange

End

ole

ak

Mig

rati

on

Inte

grit

y

Tech

nic

al

Failu

re

Co

nve

rsio

n

De

ath

Wit

hd

raw

n/

Lost

Originally Enrolled2 192

Implant and <1Mo Events 4 3 2 0

1 Month (±2 weeks) 190

186

(98%)

174

(92%)

174

(92%) ---

129

(68%)

101

(54%) ---

152

(80%)

163

(86%)

164

(86%)

Events >1Mo and <6Mo --- 0 6 3

6 Months (±1 month) 181

171

(94%)

171

(94%)

171

(94%) ---

118

(65%)

161

(89%)

161

(89%)

147

(82%)

153

(85%)

162

(90%)

Events >6Mo and <1Yr --- 0 5 2

1 Year (±2 months) 174

157

(90%)

156

(90%)

144

(83%) ---

146

(84%)

156

(90%)

156

(90%)

138

(79%)

147

(84%)

151

(87%)

Events >1Yr and <2Yrs --- 1 7 4

2 Years (±3 months) 162

152

(94%)

145

(90%)

145

(90%) ---

135

(83%)

145

(90%)

145

(90%)

119

(73%)

133

(82%)

135

(83%)

Events >2Yrs and <3Yrs --- 0 3 8


147

(97%)

130

(86%)

130

(86%) ---

119

(79%)

130

(86%)

130

(86%)

103

(68%)

122

(81%)

119

(79%)



132

(97%)

121

(89%)

121

(89%) ---

113

(83%)

121

(89%)

121

(89%)

97

(71%)

120

(88%)

113

(83%)



108

(93%)

107

(92%)

107

(92%) ---

101

(87%)

107

(92%)

107

(92%)

87

(75%)

104

(90%)

101

(87%)

1Data analysis sample size variability is due to patient availability for follow-up, as well as, quantity and quality of images available from specific timepoints for analysis. 2Of the 192 patients enrolled, four are considered technical failures due to: intraoperative conversion to open repair [n=3]; implant of a non-study device due to access issues [n=1]. Patients continued to return for follow-up.

In cases where imaging data at a timepoint were not available, subsequent timepoint imaging data were used.

Note: The number of patients who did not withdraw from the study but who missed clinical or imaging visits are: 1Yr (17); 2 Yrs (10); 3 Yrs (4); 4Yrs (4); 5Yrs (4).

Table 2. Patient Accountability – Infrarenal Bifurcated Study Surgical Control Group

Interval Patient Follow-up: n (% of eligible) Events Occurring Before Next Visit

Eligible Clinical Follow-up Death Withdrawn/Lost

Originally Enrolled 66

Events after surgery but before 1-month visit 4 0

1 Month (±2 weeks) 62 59 (95%)

Events >1Mo and <6Mo 1 2

6 Month s (±1 month) 59 54 (92%)

Events >6 Months and <1 Yr 1 8

1 Year (±2 months) 50 46 (92%)

Events >1Yr and <2 Yrs 1 6

2 Years (±3 months) 43 37 (86%)


3 Years (±3 months) 38 34 (89%)

Events >3Yrs and <4 Yrs 1 6

4 Years (±3 months) 31 30 (97%)


5 Years (±3 months) 27 26 (96%)


MM1059 Rev 01 11

Table 3. Patient and Imaging Accountability – Suprarenal Bifurcated Study Test Group1

Interval

Patient Follow-up

n (% of eligible)

Pts. with Imaging

n (% of eligible)

Pts. with Adequate Imaging to

Assess Parameter -- n (%of eligible)


Next Visit

Elig

ible

Clin

ical

Follo

w-u

p

Imag

ing

Follo

w-u

p

CT

Scan

(Co

re L

ab)

Du

ple

x

Ult

raso

un

d

KU

B Im

agin

g

An

eu

rysm

Size

An

eu

rysm

Size

Ch

ange

End

ole

ak

Mig

rati

on

Inte

grit

y

Tech

nic

al

Failu

re

Co

nve

rsio

n

De

ath

Wit

hd

raw

n/

Lost


Events after Implant and

<1Mo

3 1 0 2


141

(94%)

138

(92%)

138

(92%)

2

(1.3%)

131

(87%)

136

(91%)

136

(91%)

138

(93%)

134

(89%)

135

(90%)



122

(82%)

115

(78%)

115

(78%)

3

(2.0%)

124

(90%)

115

(78%)

115

(78%)

115

(78%)

113

(76%)

113

(76%)

Events >6Mo and <1Yr --- 2 7 3


125

(92%)

111

(82%)

114

(84%)

4

(2.9%)

121

(89%)

113

(83%)

113

(83%)

114

(84%)

111

(82%)

111

(82%)



104

(79%)

89

(68%)

89

(68%)

4

(3.1%)

81

(62%)

89

(68%)

89

(68%)

89

(68%)

89

(68%)

89

(68%)


3 Years (±3 months) 118 84

(71%)

74

(63%)

74

(63%)

7

(5.9%)

57

(48%)

74

(63%)

74

(63%)

74

(63%)

74

(63%)

74

(63%)



72

(69%)

54

(52%)

54

(52%)

5

(4.8%)

48

(46%)

54

(52%)

54

(52%)

54

(52%)

54

(52%)

54

(52%)



63

(80%)

50

(63%)

50

(63%)

7

(8.9%)

45

(57%)

50

(63%)

50

(63%)

50

(63%)

50

(63%)

50

(63%)

1Data analysis sample size variability is due to patient availability for follow-up and quantity and quality of images available from specific timepoints for evaluation. 2Of the 153 patients enrolled, three are considered technical failures due to: intraoperative conversion to open repair [n=1]; implant of a non-study

device due to access issues [n=1]; and intraoperative death [n=1]. Two of these patients withdrew at 1Mo.


Note: The number of patients who did not withdraw from the study but who missed a visit are: 1Mo (9); 6Mo (24): 1Yr (11); 2 Yrs (27); 3 Yrs (34); 4Yrs (32); 5Yrs (16).


MM1059 Rev 01 12

Table 4. Patient and Imaging Accountability – XL Aortic Extension Study1

Interval

Patient Follow-up

n (% of eligible)

Pts. with Imaging

n (% of eligible)


Parameter: n (% of eligible)


Next Visit

Elig

ible

Clin

ical

Follo

w-u

p

Imag

ing

Follo

w-u

p

CT

Scan

(Co

re L

ab)

Du

ple

x

Ult

raso

un

d

KU

B Im

agin

g

An

eu

rysm

Size

An

eu

rysm

Size

Ch

ange

End

ole

ak

Mig

rati

on

Inte

grit

y

Tech

nic

al

Failu

re

Co

nve

rsio

n

De

ath

Wit

hd

raw

n/

Lost



<1Mo

1 0 0 0


60

(100%)

59

(98%)

59

(98%)

--- 53

(88%)

56

(93%)

--- 59

(98%)

59

(98%)

59

(98%)

Events >1Mo and <6Mo 0 2 0


58

(100%)

55

(95%)

55

(95%)

--- 53

(91%)

55

(95%)

55

(95%)

55

(95%)

55

(95%)

54

(93%)

Events >6Mo and <1Yr 0 3 0


51

(93%)

50

(91%)

50

(91%)

--- 46

(84%)

50

(91%)

50

(91%)

50

(91%)

50

(91%)

50

(91%)



48

(96%)

48

(96%)

43

(86%)

3

(6.0%)

34

(68%)

43

(86%)

43

(86%)

43

(86%)

43

(86%)

43

(86%)



32

(78%)

31

(76%)

29

(71%)

1

(2.4%)

25

(61%)

29

(71%)

29

(71%)

29

(71%)

29

(71%)

29

(71%)



30

(83%)

30

(83%)

27

(75%)

2

(5.6%)

23

(64%)

27

(75%)

27

(75%)

27

(75%)

27

(75%)

27

(75%)



21

(81%)

24

(92%)

20

(77%)

3

(12%)

14

(54%)

20

(77%)

20

(77%)

20

(77%)

20

(77%)

20

(77%)

1Data analysis sample size variability is due to patient availability for follow-up and quantity and quality of images available from specific timepoints for evaluation.


Note: The number of patients who did not withdraw from the study but who missed specific visits are as follows: 1Yr (4); 2 Yrs (2); 3 Yrs (9); 4Yrs (6); 5Yrs (5).


MM1059 Rev 01 13

Table 5. Patient and Imaging Accountability – Suprarenal Aortic Extension Study1

Interval

Patient Follow-up

n (% of eligible)

Pts. with Imaging

n (% of eligible)




Next Visit

Elig

ible

Clin

ical

Follo

w-u

p

Imag

ing

Follo

w-u

p

CT

Scan

(Co

re L

ab)

Du

ple

x

Ult

raso

un

d

KU

B

Imag

ing

An

eu

rysm

Size

An

eu

rysm

Size

Ch

ange

End

ole

ak

Mig

rati

on

Inte

grit

y

Tech

nic

al

Failu

re

Co

nve

rsio

n

De

ath

Wit

hd

raw

n

/ Lo

st



<1Mo

0 0 0 2


42

(100%)

42

(100%)

41

(98%)

1

(2%)

36

(86%)

41

(98%) 41

(98%) 42

(100%)

41

(98%) 41

(98%)

Events >1Mo and <6Mo 0 3 0


36

(92%)

36

(92%)

30

(77%) ---

23

(59%)

30

(77%)

30

(77%)

30

(77%)

26

(67%)

26

(67%)

Events >6Mo and <1Yr 0 1 5


30

(91%)

30

(91%)

29

(88%) ---

22

(67%)

24

(73%)

24

(73%)

24

(73%)

29

(88%)

24

(73%)



26

(93%)

26

(93%)

20

(71%) ---

17

(61%)

20

(71%)

20

(71%)

20

(71%)

20

(71%)

20

(71%)



18

(90%)

18

(90%)

16

(80%) ---

17

(75%)

16

(80%)

16

(80%)

16

(80%)

16

(80%)

16

(80%)



13

(93%)

13

(93%)

7

(50%) ---

4

(29%)

7

(50%)

7

(50%)

7

(50%)

7

(50%)

7

(50%)



8

(100%)

8

(100%)

4

(50%) ---

3

(38%)

4

(50%)

4

(50%)

4

(50%)

4

(50%)

4

(50%)

1Data analysis sample size variability is due to patient availability for follow-up and quantity and quality of images available from specific timepoints for evaluation. In cases where imaging data at a timepoint were not available, subsequent timepoint imaging data were used.

Table 6. Patient and Imaging Accountability – PEVAR Trial Allocated Groups

Interval

Patient Follow-up

n (% of eligible)

Pts. with Imaging

n (% of eligible)




Next Visit

Elig

ible

Clin

ical

Follo

w-u

p

Imag

ing

Follo

w-u

p

CT

Scan

Fem

ora

l

Ult

raso

un

d

KU

B Im

agin

g

An

eu

rysm

Size

An

eu

rysm

Size

Ch

ange

End

ole

ak

Mig

rati

on

Inte

grit

y

Tech

nic

al

Failu

re

Co

nve

rsio

n

De

ath

Wit

hd

raw

n/

Lost

PEVAR/ProGlide Group (N=50 Originally Enrolled)

Events after Implant and <1Mo 0 0 0 0

1 Month (±2 weeks) 50 50

(100%)

50

(100%)

50

(100%)

--- --- 50

(100%)

50

(100%)

50

(100%)

50

(100%)

50

(100%)



47

(98%)

48

(100%)

--- 48

(100%)

--- --- --- --- --- ---

Femoral Exposure/Standard EVAR (SEVAR) Group (N=50 Originally Enrolled)

Events after Implant and <1Mo 1 0 0 0

1 Month (±2 weeks) 50 50

(100%)

50

(100%)

50

(100%)

--- --- 50

(100%)

50

(100%)

50

(100%)

50

(100%)

50

(100%)



43

(98%)

42

(95%) ---

42

(95%)

--- --- --- --- --- ---


MM1059 Rev 01 14

Aneurysm-Related Mortality Aneurysm-related mortality is defined as any death within 30 days of implantation, regardless of cause;

and any death after 30 days due to aneurysm rupture, a primary or secondary procedure, or surgical

conversion. Table 7 summarizes the aneurysm-related deaths in the Infrarenal Bifurcated Test, Surgical

Control, Suprarenal Bifurcated Test, XL Study, Suprarenal Aortic Extension, and PEVAR Trial groups.

Table 7. Aneurysm-Related Death Summaries By Study Group

Days Post-Op Patient

Age Patient Gender

Summary

Infrarenal Test Group

1 83 M Cardiac arrest

9 80 F Myocardial infarction after attempted thoracic repair with Talent endograft

33 76 M Ischemic heart disease

403 73 F Death during conversion to open repair after iliac artery rupture during attempted secondary endovascular intervention for proximal Type I endoleak.

Suprarenal Test Group

0 82 M Cardiopulmonary arrest secondary to iliac artery rupture/hemorrhage

3 83 M Macroembolization involving the bowel and intraabdominal organs

43 78 M Multi-organ failure

Surgical Control Group

3 69 M Metabolic acidosis

9 79 F Pulmonary embolism

10 77 F Cardiopulmonary arrest

18 81 F Acute respiratory distress syndrome

XL Study Group

None --- --- ---

Suprarenal Aortic Extension Group

None --- --- ---


MM1059 Rev 01 15

Figure 1 presents the Kaplan-Meier analysis of aneurysm-related mortality in the Infrarenal Bifurcated Test

Group, Suprarenal Bifurcated Test Group, and the Surgical Control Group.

Figure 1. Freedom from Aneurysm-Related Mortality to 5 Years, Infrarenal Bifurcated Test, Suprarenal Bifurcated Test, and Surgical Control Groups

Timepoint

Powerlink Infrarenal Powerlink Suprarenal Surgical Control

No. at Risk Survival No. at Risk Survival No. at Risk Survival

1 Month 190 0.99 151 0.99 62 0.94

6 Months 180 0.98 146 0.98 59 0.94

1 Year 175 0.98 137 0.98 53 0.94

2 Years 164 0.98 122 0.98 43 0.94

3 Years 148 0.98 112 0.98 39 0.94

4 Years 129 0.98 88 0.98 33 0.94

5 Years 77 0.98 62 0.98 17 0.94


MM1059 Rev 01 16

All-Cause Mortality Figure 2 presents the Kaplan-Meier analysis of all-cause mortality in the Infrarenal Bifurcated Test, Suprarenal

Bifurcated Test Group, and the Surgical Control Group.

Figure 2. Freedom from All-Cause Mortality to 5 Years, Infrarenal Bifurcated, Suprarenal Bifurcated, and SurgicalControl Groups

Timepoint



1 Month 190 0.99 150 0.99 62 0.94

6 Months 180 0.96 146 0.97 59 0.92

1 Year 175 0.94 137 0.93 53 0.88

2 Years 164 0.91 122 0.88 43 0.84

3 Years 148 0.88 112 0.87 39 0.78

4 Years 129 0.82 88 0.79 33 0.76

5 Years 77 0.77 62 0.77 17 0.73


MM1059 Rev 01 17

A summary of the deaths reported to date in each study test group and in the surgical control group is provided in Table 8, organized by probable body system. If the death occurred within 30 days, or otherwise was found to be aneurysm-related, it is listed as such. These deaths were previously detailed in Table 5. Among the study groups, the largest causative categories are cancer-related, cardiac related, and pulmonary-related.

Table 8 Summary of All-Cause Deaths to 5 Years Listed by Probable Body System Relatedness

Category/Body System Relatedness

Infrarenal Bifurcated [N=192]

Suprarenal Bifurcated

[N=153]

Surgical Control [N=66]*

XL Aortic Extension

[N=60]

Suprarenal Aortic Extension

[N=44]

PEVAR Randomized Trial [N=151]

n (%) n (%) n (%) n (%) n (%) n (%)

Aneurysm-Related 4 (2.1%) 3 (2.0%) 4 (6.1%) 0 0 1 (0.7%)

Cancer-Related 14 (7.3%) 5 (3.3%) 5 (7.6%) 6 (10%) 1 (2.3%) 2 (1.4%)

Cardiac-Related 8 (4.2%) 11 (7.1%) 3 (4.5%) 3 (5.0%) 0 1 (0.7%)

Cerebrovascular-Related 3 (1.6%) 2 (1.3%) 1 (1.5%) 2 (3.3%) 2 (4.6%) 0

Gastrointestinal-Related 1 (0.5%) 0 0 0 1 (2.3%) 0

Pulmonary-Related 8 (4.2%) 8 (5.2%) 2 (3.0%) 3 (5.0%) 4 (9.1%) 0

Other†

4 (2.1%) 4 (2.6%) 2 (3.0%) 4 (6.7%) 1 (2.3%) 0

†Other includes: Liver cirrhosis, multiorgan failure, kidney failure, sepsis, and natural causes (Infrarenal Bifurcated Test group); sepsis; asphyxial suicide, unknown, and natural causes (Suprarenal Bifurcated Test group); multiorgan failure; unknown (Control group); dementia and malnutrition, multiorgan failure, pneumonia, thrombocytopenia (XL group); accidental fall (Suprarenal extension group).

*Deaths reported to Endologix that occurred after the final protocol-specified follow-up are included (cancer [1]; cardiac [1]).

Major Adverse Events The protocol-specified primary safety endpoint in the Infrarenal and Suprarenal Bifurcated studies is the proportion of patients with a major adverse event (MAE) within one year compared to the surgical control

group.† Through one year, patients treated with the Endologix stent graft in both studies experienced fewer MAEs compared with control patients treated with open surgery. In each study, hypothesis testing of the study results met the one-year safety endpoint success criterion. MAEs reported from the time of enrollment through one year (0 Days-1 Year), and after one year through

current follow-up to five years (>1 Year-5 Years) are presented in Table 9.

Within one year, fewer study patients experienced an MAE compared with patients treated with open surgery.

Longer term follow-up of patients in the test group included clinical visits as well as Core Laboratory evaluated

diagnostic imaging results (CT scans and x-rays). Longer term follow-up in control group patients who

remained in the study included primarily telephone follow-up.

Notably, no aneurysm rupture was observed throughout five-year follow-up in any study. Further details on secondary procedures are provided in the Treatment Effectiveness subpart of this Section. Additional details on explants are provided in Section 3.

†MAE in these studies is a composite endpoint consisting of: all-cause death; aneurysm rupture; conversion to open repair; myocardial

infarction; coronary intervention; renal failure; respiratory failure; secondary intervention; and stroke.


MM1059 Rev 01 18

Table 9. MAEs, Infrarenal Bifurcated and Suprarenal Bifurcated Test vs. Control1

Parameter

0 Days-1 Year2

>1 Year-5 Years2

Infra Test n (%)

Supra Test n (%)

Control n (%)

Infra Test n (%)

Supra Test n (%)

Control n (%)

Number of Patients 192 153 66 173 131 48

Patients with ≥1 MAE 46 (24%) 32 (21%) 22 (33%) 64 (37%) 54 (41%) 8 (17%)

All-Cause Mortality3

13 (6.8%) 12 (7.8%) 9 (14%) 30 (17%) 22 (17%) 6 (13%)

AAA Rupture 0 0 --- 0 0 ---

Conversion/Explant 4 (2.1%) 2 (1.3%) --- 0 4 (3.1%) ---

Coronary Intervention 3 (1.6%) 5 (3.3%) 0 22 (13%) 8 (6.1%) 2 (4.2%)

Myocardial Infarction 7 (3.7%) 1 (0.7%) 6 (9.1%) 11 (6.5%) 5 (3.8%) 1 (2.1%)

Renal Failure 6 (3.1%) 3 (2.0%) 7 (11%) 1 (0.6%) 3 (2.3%) 0

Respiratory Failure 4 (2.1%) 4 (2.6%) 5 (7.6%) 2 (1.2%) 2 (1.5%) 0

Secondary Procedure 20 (10%) 12 (8.8%) 2 (3.0%) 11 (6.5%) 20 (15%) 0

Stroke 5 (2.6%) 2 (1.3%) 2 (3.0%) 10 (5.8%) 1 (0.8%) 0

1Enrolled patients: Infrarenal Bifurcated Test: N=192; Suprarenal Bifurcated Test: N=153; Control: N=66. Results (n) shown as number of patients with at least one event (% of patients available in group). Some patients may experience more than one event.

2The events in the grouping 0 Days-1 Year includes all events occurring up to 14 months post-procedurally. The events in the grouping >1 Year-5 Years include all events after 14 months and up to 62 months post-procedurally.

3All deaths within 30 days are considered AAA and procedure related. Of the late Powerlink deaths, one occurring at approximately one year was considered AAA and procedure related.


MM1059 Rev 01 19

Figure 3 presents the Kaplan-Meier analysis of major adverse events in the Infrarenal Bifurcated Test,

Suprarenal Bifurcated Test Group, and the Open Surgical Control Group.

Figure 3. Freedom from Major Adverse Events to 5 Years, Infrarenal Bifurcated, Suprarenal Bifurcated, and SurgicalControl Groups

Timepoint



1 Month 182 0.95 144 0.94 51 0.77

6 Months 162 0.85 133 0.87 49 0.76

1 Year 150 0.80 120 0.80 42 0.69

2 Years 128 0.70 102 0.70 37 0.66

3 Years 113 0.66 88 0.65 33 0.61

4 Years 91 0.56 68 0.59 30 0.61

5 Years 53 0.47 44 0.53 18 0.58


MM1059 Rev 01 20

MAEs reported in the XL and Suprarenal Aortic Extension studies through one year are itemized in Table 10. Results are consistent with the Infrarenal and Suprarenal Bifurcated studies, and with the natural progression of this elderly patient population. Notably, no aneurysm rupture was observed in follow-up. One conversion to open repair was performed

in one XL patient in conjunction with a total open repair of a thoracic aortic aneurysm. Further details on

secondary procedures are provided in the Treatment Effectiveness subpart of this Section.

Table 10. MAEs, XL and Suprarenal Aortic Extension Test Groups1

Parameter

0-30 Days2 0 Days-1 Year

2 >1 Year to 5 Years

2

XL Test n (%)

Supra Ext. Test n (%)

XL Test n (%)


XL Test n (%)


Number of patients 60 44 60 44 50 28

Patients with ≥1 MAE 1 (1.7%) 1 (2.3%) 10 (17%) 9 (20%) 22 (44%) 9(32%)

All-Cause Death3

0 0 5 (8.3%) 4 (9.1%) 13 (26%) 5 (18%)

AAA Rupture 0 0 0 0 0 0

Conversion/Explant 0 0 0 0 1 (2.0%) 0

Coronary Intervention 0 0 0 0 4 (8.0%) 1 (3.6%)

Myocardial Infarction 0 0 1 (1.7%) 1 (2.3%) 3 (6.0%) 0

Renal Failure 0 1 (2.3%) 3 (5.0%) 2 (4.5%) 3 (6.0%) 2 (7.2%)

Respiratory Failure 1 (1.7%) 1 (2.3%) 2 (3.3%) 2 (4.5%) 3 (6.0%) 1 (3.6%)

Secondary Procedure 0 0 1 (1.7%) 5 (11%) 4 (8.0%) 2 (7.2%)

Stroke 0 0 3 (5.0%) 0 2 (4.0%) 0

1XL: N=60; Suprarenal Aortic Extension: N=44. Results (n) shown as number of patients with at least one event (% of patients available in group). Some patients may experience more than one event.

2The events in the grouping 0-30 days include all events procedurally and up to and including exactly 30 days post-procedurally. The events in the grouping 0 Days-1 Year include all events procedurally and up to 365 days post-procedurally.

3Of the late deaths (>30 days), none was considered AAA or procedure related.


MM1059 Rev 01 21

In the PEVAR Trial, procedural technical success among the study groups was 94% (PEVAR/ProGlide) and 98% (SEVAR).† MAEs and vascular complications reported in the PEVAR Trial are itemized in Table 11. Across groups, a low rate of events was observed.

Table 11. MAEs and Vascular Complications, PEVAR Trial Randomized Groups1

Parameter

0-30 Days2 31 Days-6 Months

2

PEVAR/PG n (%)

SEVAR/FE n (%)

PEVAR/PG n (%)

SEVAR/FE n (%)

Major Adverse Events

Number of patients 50

50 47

43

Patients with ≥1 MAE 2 (4.0%)

5 (10%) 1 (2.1%)

3 (7.0%)

All-Cause Death3

0

0 0

1 (2.3%)

AAA Rupture 0

0 0

0

Conversion/Explant 0

0 0

0

Bowel Ischemia 0

0 0

0

Cardiac Morbidity 0

0 0

0

Neurological Complication 0

3 (6.0%) 0

0

Renal Failure 2 (4.0%)

1 (2.0%) 1 (2.1%)

0

Respiratory Failure 1 (2.0%)

1 (2.0%) 0

0

Secondary Procedure 0

2 (4.0%) 0

2 (4.6%)

Vascular Complications

Patients with ≥1 Event 4 (8.0%)

8 (16%) 2 (4.2%)

1 (2.3%

Arteriovenous Fistula 0

0 0

0

Femoral Neuropathy 0

1 (2.0%) 0

0

Hematoma 0

0 0

0

Hemorrhage 1 (2.0%)

3 (6.0%) 0

0

Infection 0

0 0

0

Lymphocele 0

1 (2.0%) 0

1 (2.3%)

Distal Thrombosis/Stenosis 2 (4.0%)

3 (6.0%) 0

0

Vascular Injury 1 (2.0%)

1 (2.0%) 2 (4.2%)

0

1PEVAR/PG (ProGlide): N=50; SEVAR/FE (femoral exposure): N=50. Results (n) shown as number of patients with at least one event (% of patients available in group). Some patients may have experienced more than one event.

2The events in the grouping 0-30 days include all events procedurally and up to 30 days post-procedurally. The events in the grouping 31 Days-6 Months include all events from day 31 to 183 post-procedurally.

3Of the late deaths (>30 days), none were considered AAA or procedure related.

†Procedural technical success is defined as successful vascular access per randomized assignment and without conversion to

femoral exposure in percutaneous groups, and successful endovascular device delivery and deployment using the study device.


MM1059 Rev 01 22

Treatment Effectiveness

Aneurysm Sac Exclusion. The Core Laboratory assessed CT scans to determine the effectiveness of aneurysm sac exclusion, as measured by maximum diameter changes over time. Consistent with the literature, aneurysm sac diameter decrease or increase was defined as a change of >5mm compared to baseline.1 A summary of the results to five years is presented in Table 12 and Table 13.

No aneurysm rupture has occurred in any patient. At five years, the large majority of patients in each study

were observed with stable or decreased aneurysm sac diameter. These long-term data are consistent in

demonstrating effective aneurysm sac exclusion. Since the ePTFE grafts used in all of the clinical studies are

identical in size, design, and processing, a similar rate of sac increase was anticipated in the absence of other

variables. Slightly higher rates of increased aneurysm sac diameter reported in the Suprarenal Bifurcated, XL,

and Suprarenal Aortic Extension studies compared to the Infrarenal Bifurcated study. These higher rates were

attributed to Type II endoleaks in the majority of patients (Type I endoleak was causal in six patients).

Core laboratory comparison of the Type II endoleak rates among the Infrarenal Bifurcated and Suprarenal

Bifurcated studies demonstrates a substantial disparity in the prevalence of Type II endoleaks (23% Suprarenal

vs. 15% Infrarenal) categorized as moderate to severe due to a patent IMA or multiple lumbar arteries (60%

Suprarenal vs. 42% Infrarenal). As reported in the literature, the incidence of Type II endoleak varies in the

endovascularly-treated population from 8% to 32%.2 It is therefore plausible that the difference in aneurysm

sac enlargement in the XL and Suprarenal Aortic Extension clinical studies is also due to differences in the

prevalence and severity of Type II endoleak due to large patent IMA or lumbar arteries.

Table 12. Aneurysm Sac Diameter Change Over Time, Infrarenal and Suprarenal Bifurcated Studies

Change* 1 Year

% (n/N) 2 Years % (n/N)

3 Years % (n/N)

4 Years % (n/N)

5 Years % (n/N)

Infrarenal Bifurcated Test Group

No Growth 99% (154/156) 97% (141/145) 96% (125/130) 96% (116/121) 92% (98/107)

Decreased 37% (57/156) 54% (78/145) 60% (78/130) 66% (80/121) 71% (76/107)

Stable 62% (97/156) 43% (63/145) 36% (47/130) 30% (36/121) 21% (22/107)

Increased 1.3% (2/156) 2.8% (4/145) 3.8% (5/130) 4.1% (5/121) 8.4% (9/107)

Suprarenal Bifurcated Test Group

No Growth 91% (106/117) 91% (77/85) 86% (64/74) 89% (48/54) 86% (43/50)

Decreased 52% (61/117) 38% (32/85) 49% (36/74) 59% (32/54) 50% (25/50)

Stable 38% (45/117) 53% (45/85) 38% (28/74) 30% (16/54) 36% (18/50)

Increased 9.4% (11/117) 9% (8/85) 14% (10/74) 11% (6/54) 14% (7/50)

Includes evaluable CTs received and reviewed by the Core Lab.

*No Growth: Decreased + Stable; Decreased: >5mm reduction; Stable: 5mm or less change; Increased: >5mm increase.

Among patients identified with a sac diameter increase, all but one was attributed to Type II endoleak. This one patient (Suprarenal Bifurcated Study, 1-Year follow-up) was identified with both a Type I and Type II endoleak.

1Chaikof EL. Capturing an accurate measure of success-outcomes and endpoints in endovascular aneurysm repair. J Vasc Surg 2002;36:410-1. 2Heikkinen MA, Arko FR, and Zarins CK. What is the significance of endoleaks and endotension? Surg Clin N Am 2004;84:1337-52.


MM1059 Rev 01 23

Table 13. Aneurysm Sac Diameter Change Over Time, XL and Suprarenal Aortic Extension Studies

Change* 1 Year

% (n/N) 2 Years % (n/N)

3 Years % (n/N)

4 Years % (n/N)

5 Years % (n/N)

XL Aortic Extension Test Group

No Growth 98% (50/51) 93% (42/45) 80% (24/30) 91% (20/22) 92% (11/12)

Decreased 27% (14/51) 51% (23/45) 57% (17/30) 77% (17/22) 67% (8/12)

Stable 71% (36/51) 44% (19/45) 23% (7/30) 14% (3/22) 25% (3/12)

Increased 2.0% (1/51) 7.0% (3/45) 20% (6/30) 9.1% (2/22) 8.3% (1/12)

Suprarenal Aortic Extension Test Group

No Growth 88% (21/24) 100% (20/20) 88% (14/16) 86% (6/7) 100% (4/4)

Decreased 38% (9/24) 45% (9/20) 50% (8/16) 43% (3/7) 75% (3/4)

Stable 50% (12/24) 55% (11/20) 38% (6/16) 43% (3/7) 25% (1/4)

Increased 12% (3/24) 0 12% (2/16) 14% (1/7) 0

Includes evaluable CTs received and reviewed by the Core Lab.

*No Growth: Decreased + Stable; Decreased: >5mm reduction; Stable: 5mm or less change; Increased: >5mm increase.

Among patients identified with a sac diameter increase, the majority were attributed to Type II endoleak. The exceptions in each study are as follows: XL Aortic Extension Study: 2 patients at the 2-year and 3-year follow-up were observed with a Type I and Type II endoleak. Suprarenal Aortic Extension Study: 2 patients at the 1-year follow-up and 1 patient at the 3-year follow-up were observed with a Type I endoleak.

Migration. The Core Laboratory assessed CT scans to determine distal device movement relevant to the

initial implant location (baseline CT scan) at each follow-up. Consistent with the literature, migration is

defined as device movement of >10mm relative to the original implant location.

In the Infrarenal Bifurcated study, a total of eight patients (4.2%) were observed with distal migration over

five years; secondary proximal extension placement was performed in two patients (no endoleak). In the

Suprarenal Bifurcated study, a total of three patients (2.0%) have been observed with distal migration; only

one required proximal extension placement. Among the XL and Suprarenal Aortic Extension studies, one

patient with a rapidly enlarging thoracic aortic aneurysm was identified with neck dilation and migration, and

underwent a total open repair of the thoracic and abdominal aorta at 22 months. No migration of an

anatomically-fixed bifurcated stent graft was observed.


MM1059 Rev 01 24

Endoleak Incidence. The Core Laboratory assessed CT scans to determine the presence of endoleak at each

follow-up. Available results to five years are presented in Table 14. The majority of endoleaks are Type II

(collateral vessel-related). Moreover, there have been no Type III or IV endoleaks reported by the Core

Laboratory at any time period. Interventions for endoleak are described later in this section.

Table 14. Endoleak Incidence (Core Laboratory)

Endoleak Type 1 Month

% (n/N)

1 Year

% (n/N)

2 Years

% (n/N)

3 Years

% (n/N)

4 Years

% (n/N)

5 Years

% (n/N)

Type IA Endoleak

Infra Bifurcated 2.0% (3/152) 0.7% (1/138) 0.8% (1/119) 0.0% (0/103) 0.0% (0/97) 0.0% (0/87)

Supra Bifurcated 4.6% (6/130) 2.8% (3/105) 2.4% (2/85) 1.4% (1/74) 1.9% (1/54) 2.0% (1/50)

XL 0.0% (0/59) 2.0% (1/50) 0.0% (0/43) 3.6% (1/28) 8.3% (1/24) 0.0% (0/12)

Supra Extension 4.8% (2/41) 0.0% (0/24) 5.0% (1/20) 11% (2/16) 0.0% (0/7) 0.0% (0/4)

Type IB Endoleak

Infra Bifurcated 0.0% (0/152) 0.0% (0/138) 0.0% (0/119) 0.0% (0/103) 0.0% (0/97) 0.0% (0/87)

Supra Bifurcated 0.8% (1/130) 2.8% (3/105) 0.0% (0/85) 0.0% (0/74) 0.0% (0/54) 0.0% (0/50)

XL 0.0% (0/59) 0.0% (0/50) 0.0% (0/43) 0.0% (0/28) 0.0% (0/24) 0.0% (0/12)

Supra Extension 0.0% (0/41) 3.3% (1/24) 5.0% (1/20) 0.0% (0/16) 0.0% (0/7) 0.0% (0/4)

Type II Endoleak

Infra Bifurcated 19% (29/152) 12% (17/138) 9.2% (11/119) 5.8% (6/103) 10% (10/97) 11% (10/87)

Supra Bifurcated 37% (48/130) 27% (28/105) 19% (16/85) 22% (16/74) 13% (7/54) 12% (6/50)

XL 22% (13/59) 16% (8/50) 14% (6/43) 11% (3/28) 12% (3/24) 8.3% (1/12)

Supra Extension 15% (6/41) 21% (5/24) 5.0% (1/20) 0.0% (0/16) 0.0% (0/7) 0.0% (0/4)

Endoleaks reported are not cumulative but are those identified at each time point.

Note: at both one month and one year, one Infrarenal patient and four Suprarenal patients have more than one type of endoleak and are included in multiple rows.


MM1059 Rev 01 25

Secondary Interventions. The number of patients who underwent a secondary intervention following the

index procedure are shown in Table 15 by study and by follow-up interval. Among the studies, no interventions

for Type III or IV endoleak occurred.

Table 15. Patients with Secondary Interventions

Reason for Intervention

≤1 Month

n/N (%)

31 Days-1 Yr

n/N (%)

>1Yr-2 Yrs

n/N (%)

>2Yrs-3Yrs

n/N (%)

>3Yrs-4Yrs

n/N (%)

>4Yrs-5Yrs

n/N (%)

Infrarenal Bifurcated Study

Type IA Endoleak 2/186 (1.1%) 2/171 (1.2%) 0/152 (0.0%) 0/147 (0.0%) 0/132 (0.0%) 0/108 (0.0%)

Type IB Endoleak 0/186 (0.0%) 2/171 (1.2%) 0/152 (0.0%) 1/147 (0.7%) 0/132 (0.0%) 0/108 (0.0%)

Type II Endoleak 1/186 (0.6%) 5/171 (2.9%) 4/152 (2.6%) 2/147 (1.4%) 2/132 (1.5%) 1/108 (0.9%)

Limb Occlusion 1/186 (0.6%) 5/171 (2.9%) 1/152 (0.7%) 0/147 (0.0%) 0/132 (0.0%) 0/108 (0.0%)

Other a 2/186 (1.1%) 2/171 (1.2%) 1/152 (0.7%) 0/147 (0.0%) 2/132 (1.5%) 0/108 (0.0%)

Suprarenal Bifurcated Study

Type IA Endoleak 0/149 (0.0%) 2/140 (1.4%) 2/124 (1.8%) 1/110 (0.9%) 1/84 (1.2%) 0/68 (0.0%)

Type IB Endoleak 0/149 (0.0%) 2/140 (1.4%) 0/124 (0.0%) 4/110 (3.6%) 0/84 (0.0%) 0/68 (0.0%)

Type II Endoleak 1/149 (0.7%) 5/140 (3.6%) 4/124 (3.6%) 4/110 (3.6%) 3/84 (3.6%) 1/68 (1.5%)

Limb Occlusion 2/149 (1.4%) 1/140 (0.7%) 0/124 (0.0%) 1/110 (0.9%) 1/84 (1.2%) 0/68 (0.0%)

Other b 1/149 (0.7%) 1/140 (0.7%) 0/124 (0.0%) 0/110 (0.0%) 0/84 (0.0%) 1/68 (1.5%)

XL Aortic Extension Study

Type IA Endoleak 0/60 (0.0%) 2/55 (3.6%) 1/50 (2.0%) 1/41 (2.4%) 0/36 (0.0%) 1/26 (3.8%)

Type IB Endoleak 1/60 (1.7%) 1/55 (1.8%) 0/50 (0.0%) 0/41 (0.0%) 0/36 (0.0%) 0/26 (0.0%)

Type II Endoleak 0/60 (0.0%) 1/55 (1.8%) 0/50 (0.0%) 0/41 (0.0%) 0/36 (0.0%) 0/26 (0.0%)

Limb Occlusion 0/60 (0.0%) 0/55 (0.0%) 0/50 (0.0%) 0/41 (0.0%) 0/36 (0.0%) 0/26 (0.0%)

Other c 0/60 (0.0%) 0/55 (0.0%) 1/50 (2.0%) 0/41 (0.0%) 0/36 (0.0%) 0/26 (0.0%)

Suprarenal Aortic Extension Study

Type IA Endoleak 0/44 (0.0%) 1/33 (3.0%) 0/28 (0.0%) 0/20 (0.0%) 0/14 (0.0%) 0/8 (0.0%)

Type IB Endoleak 0/44 (0.0%) 0/33 (0.0%) 1/28 (3.6%) 0/20 (0.0%) 0/14 (0.0%) 0/8 (0.0%)

Type II Endoleak 0/44 (0.0%) 1/33 (3.0%) 2/28 (7.2%) 1/20 (5.0%) 0/14 (0.0%) 0/8 (0.0%)

Limb Occlusion 0/44 (0.0%) 1/33 (3.0%) 0/28 (0.0%) 0/20 (0.0%) 0/14 (0.0%) 0/8 (0.0%)

Other d 0/44 (0.0%) 1/33 (3.0%) 0/28 (0.0%) 0/20 (0.0%) 0/14 (0.0%) 0/8 (0.0%)

aExternal iliac artery stenting or femoral thrombectomy (1Mo); distal limb embolectomy, sac fluid aspiration (1Yr); unknown endoleak (2Yrs); migration in two patients (4Yrs)

bGroin lymph leak (1Mo); distal alignment absent endoleak (1Yr); migration absent endoleak (5Yrs) cThoracic aneurysm expansion (descending and abdominal aortic surgical repair) dUnknown endoleak


MM1059 Rev 01 26

Device Integrity. Core laboratory evaluations of the implanted stent graft performance include abdominal

radiograph evaluations of the stent and CT scan evaluations of stent graft patency and integrity (including

stent fracture, graft fatigue, an obstruction of any kind, or a device kink or alignment observation). No patient

was identified with a stent fracture or graft failure at any follow-up. Among all of the studies, four patients were

identified with a slight, non-clinically significant stent kink. No interventions were performed in these patients.

Summary

Among four nonrandomized pivotal studies of the Endologix stent graft, primary safety and effectiveness results that served as the basis for FDA approval of the endograft met the prospectively defined acceptance criteria. Through one year, patients in the original studies who received the Infrarenal or Suprarenal bifurcated stent graft experienced fewer major adverse events, mortality, and aneurysm-related mortality than patients treated with open surgery. Data beyond the one-year time point continue to support device safety and effectiveness. Long-term follow-up shows similar rates of mortality and major adverse events among test groups and the surgical control group. No stent fractures or graft disruptions were observed. The majority of test patients did not experience an endoleak. Of those that did, most were Type II, with minimal Type I and no Type III or IV endoleaks observed by the Core Laboratory. At the pivotal analysis time point and through long-term follow-up, effective aneurysm sac exclusion and 100% freedom from aneurysm rupture is observed. Cumulatively, these results are consistent with the published long-term outcomes analysis of propensity-score matched Medicare patients undergoing endovascular or open repair.3,4

In the only multicenter, randomized pivotal trial of totally percutaneous endovascular aneurysm repair,

primary analyses that served as the basis for FDA approval met the prospectively defined acceptance

criterion.5 This trial has demonstrated the clinical utility, safety, and effectiveness of endovascular repair using

a totally percutaneous access approach with the Endologix sheath-based system, facilitated with the study

suture-mediated closure device. Future Plans. To study AFX outcomes in commercial use, Endologix initiated the first multicenter, prospective,

randomized study of endovascular abdominal aortic aneurysm repair (EVAR) in 2015. The LEOPARD (Looking

at EVAR Outcomes by Primary Analysis of Randomized Data) Study will randomize 800 patients 1:1 to AFX or

another commercially available stent graft, and follow patients at pre-specified timepoints for safety and

performance-related outcomes. To date, 58 sites are open for enrollment and 167 patients have been

randomized into the study. Study results will be included in future clinical updates.

The primary endpoint is survival in the absence of aneurysm-related complications at one year. The results of

the study are intended to serve as the modern reference for performance of individual EVAR devices and will

help to inform current practice and future therapy developments.

3Schermerhorn M, O’Malley AJ, Jhaveri A, et al. Endovascular vs. open repair of abdominal aortic aneurysms in the Medicare

population. N Engl J Med 2008;358:464-74. 4Giles K, Pomposelli F, Hamdan A, et al. Decrease in total aneurysm-related deaths in the era of endovascular repair. J Vasc Surg

2009;49:543-51. 5Nelson PR, Krajcer Z, Kansal N, et al. A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral

exposure for endovascular aortic aneurysm repair. J Vasc Surg 2014;59:1181-94.


MM1059 Rev 01 27

SECTION 2: Commercial Experience Endologix maintains an active customer experience reporting system to collect, evaluate, and report complaints and adverse events in compliance with US and international requirements. This section provides the cumulative experience to date for the Powerlink and AFX endograft systems.

The Powerlink System has been in commercial distribution in select countries outside of the US beginning in 2000 and in the US since FDA approval in October 2004. The AFX System was introduced in the US in August 2011 and in Europe in late 2011. The Powerlink System and AFX System are available in a number of

international markets. As of October 31, 2015, a total of 151,652 Powerlink and AFX devices were distributed globally as indicated in Table 16 below:

Table 16. Devices Sold Worldwide Device Powerlink AFX

Region Bifurcated Extensions Bifurcated Extensions

US 16,193 23,183 26,761 34,205

OUS 15,253 17,138 8,508 10,411

Total 71,767 79,885

The data in Table 17 summarize the total number of aneurysm-related mortalities and surgical conversions to open repair reported in worldwide experience through October 2015.

Table 17. Summary of Worldwide Performance

Adverse Event Type Powerlink AFX

US OUS US OUS

Aneurysm-Related Mortality* 106 14 112 7

Conversion to Open Repair 139 38 104 7

*Aneurysm-related mortality includes deaths intraoperatively to within 30 days of the procedure, and deaths secondary to aneurysm rupture or to complications during the index, secondary, or conversion procedures.

Aneurysm-Related Mortality and Surgical Conversion A total of 239 aneurysm-related deaths have been reported to Endologix in patients treated with the Powerlink System and AFX System to date in commercial experience. Most of these events involved patients with pre-existing comorbidities that contributed to the event and were associated with complications during or

secondary to the endovascular procedure, including vascular injury or perforation due to ballooning in the

proximal aortic neck, complications during introduction or withdrawal of the delivery system through calcified

or tortuous anatomy, treatment of highly angulated anatomy resulting in device malpositioning or inadvertent

covering of the renal arteries, procedural blood loss, cardiac events, respiratory failure, and ischemic events.

Surgical conversion to open repair not resulting in death has been reported in 288 patients treated with Powerlink and AFX devices. The most common contributing cause for late surgical conversion is endoleak; less common causes are device or limb occlusion particularly in narrow and calcified arteries, and aneurysm

enlargement without specified endoleak. An organized summary of the aneurysm-related mortalities and surgical conversions is provided in Table 18.


MM1059 Rev 01 28

Table 18. Aneurysm-Related Mortality and Surgical Conversion

Event Type Aneurysm-Related Mortality Surgical Conversion

Device Powerlink AFX Powerlink AFX

Comorbidity* 36 28 N/A

Procedure-Related 68 27 109 24

Post-Procedure Aneurysm Rupture, Total 3 26 9 11

Unknown Cause of Rupture 0 8 4 3

Post-Deployment Ballooning 0 0 0 1

Rupture Secondary to Endoleak (all) 3 18 5 7

Type I 0 3 2 0

Type II 0 1 1 0

Type III (component separation) 3 9 2 3

Type III (graft tear or hole) 0 3 0 3

Type Unknown 0 2 0 1

Emergent Rupture (Prior to Device Implant) ‡ 2 17 1 1

Endoleak (Non-ruptured aneurysms), Total 3 4 30 22

Type I 1 1 12 7

Type II 0 0 13 3

Type III (component separation) 2 2 4 7

Type Unknown 0 1 1 5

Aneurysm Enlargement (without Endoleak) 0 0 5 2

Post-Implant Migration or Lateral Movement 0 1 3 4

Device or Limb Occlusion 2 5 9 17

Infection 1 2 2 7

Stent Graft Integrity¥ 0 3 7 23

Unspecified 5 6 2 0

Total 120 119 177 111

*Mortalities due to comorbidity are defined as deaths due to a simultaneous patient disease or conditions secondary to the endovascular procedure; these deaths are considered secondary to procedural complications.

‡Presentation as emergent rupture resulting in conversion or death before the endovascular device could be implanted.

¥Events related to graft tear, stent compression or expansion, and damage to delivery system in calcified anatomy.

The majority of aneurysm-related deaths (75%) reported occurred at the time of the procedure or within the first 30 days after device implant secondary to procedural complications or patient comorbidity, as shown in Table 19. Late aneurysm-related mortality is primarily associated with endoleak or secondary procedures to treat endoleak and patient comorbidities.

Table 19. Occurrence of Aneurysm-Related Mortality by Time Post-Implant

Timing Intraoperative ≤30 Days 31 Days – 1 Year >1 Year – 3 Years >3 Years

Event Type

Co

mo

rbid

ity

Pro

ced

ura

l

Co

mp

licat

ion

Oth

er*

Co

mo

rbid

ity

Pro

ced

ura

l

Co

mp

licat

ion

End

ole

ak

Oth

er*

Co

mo

rbid

ity

End

ole

ak

Oth

er*

Co

mo

rbid

ity

End

ole

ak

Oth

er*

Co

mo

rbid

ity

End

ole

ak

Oth

er*

Powerlink 12 36 4 15 30 0 4 6 1 2 1 2 0 2 3 2

AFX 6 10 12 13 15 2 9 4 3 11 3 14 12 1 4 0

*Other: failed treatment of emergent aneurysms (2 Powerlink, 17 AFX), occlusion (2 Powerlink, 5 AFX), infection (1 Powerlink, 2 AFX), procedural blood loss during secondary intervention (1 AFX), stent perforation of infected aorta (1 Powerlink), ischemic bowel disease (1 Powerlink), and unknown causes (5 Powerlink, 13 AFX).


MM1059 Rev 01 29

Aneurysm Rupture Post-Procedure A total of 74 post-procedural aneurysm ruptures have been reported to Endologix since 2004, 45 of which were successfully converted to open repair [18] or resolved through secondary endovascular intervention with additional device placement [27]. These ruptures occurred between 4 days and 5 years following the original procedure, as shown in Table 20. The primary cause of rupture was reported to be Type I or Type III endoleak between 1-3 years after device implant. Specific contributing factors in these cases include inadequate component overlap or seal zone during the index procedure, placement in short necks or severely angulated (off-label) anatomy, and placement in patients at elevated risk due to initial emergent presentation.

Table 20. Occurrence of Post-Procedure Aneurysm-Rupture and Outcome by Time Post-Implant

Timing ≤30 Days 31 Days - 1 Year >1 Year – 3 Years > 3 Years

Event Type

Mo

rtal

ity

Seco

nd

ary

Pro

ced

ure

Co

nve

rsio

n t

o

Op

en

Re

pai

r

Mo

rtal

ity

Seco

nd

ary

Pro

ced

ure

Co

nve

rsio

n t

o

Op

en

Re

pai

r

Mo

rtal

ity

Seco

nd

ary

Pro

ced

ure

Co

nve

rsio

n t

o

Op

en

Re

pai

r

Mo

rtal

ity

Powerlink 0 0 0 0 2 4 1 5 5 2

AFX 2 4 1 5 12 7 16 4 1 3

Endoleak Endoleak remains a significant risk following EVAR procedures. The number of reports received in worldwide experience that were associated with endoleak treated with secondary intervention is shown in Table 21. Contributing factors associated with endoleak are related to patient anatomy, with increased incidence in patients with hostile neck anatomy, large and angulated aneurysms, inadequate overlap length between components, significant neck angulation, and aneurysm remodeling post-implant.

Table 21. Endoleak Reports

Endoleak Type Type IA Type IB Type II Type III Unknown

Powerlink 212 88 22 76 27

AFX 98 85 16 173 53

An IFU update was completed and retraining was performed beginning in mid-2013 to reinforce the importance of device selection, with an emphasis on maximizing overlap between the bifurcated and extension components. Maximizing overlap provides columnar support between the bifurcated and proximal extension, mitigating the effects of lateral forces in the mid-section of the aneurysm sac. Maximizing overlap is recommended in all AFX cases, but especially important in angulated anatomy in which the length of stent graft overlap may vary6. Reinforcement of this important factor has continued through IFU enhancements and retraining efforts conducted in 2014 and 2015. Post-market surveillance evaluation since the original retraining (occurring over two years ago) continues to show a significant reduction (~80%) in reports of Type III endoleak for AFX.

Device Integrity Device integrity events include those associated with stent kinking, compression, deformation, or fracture, as well as graft tears, holes, or suture breaks at graft or stent attachment zones (Type IIIB endoleak). Roughly half of the events were reported emergently, and the other half identified during routine surveillance. The majority of graft integrity events were reported to have occurred in or near the bifurcated region of the bifurcated stent graft and 6Figueroa CA, Taylor CA, Yeh V, et al. Effect of Curvature on Displacement Forces Acting on Aortic Endografts: A 3-Dimensional Computational Analysis. J

Endovasc Ther. 2009; 16:284-294.


MM1059 Rev 01 30

have been associated with procedural (index or secondary) related factors, such as aggressive post-dilatation ballooning or catheter/guidewire manipulation. Other identified contributing factors include device use in heavily calcified anatomy and off-label use in conjunction with physician modified devices or other (i.e., thoracic) stent grafts that could yield Type IIIA endoleaks that may result in Type IIIBs over time due to alterations in patient anatomy.

Powerlink: Two stent fractures were reported in proximal extension stent grafts between four and six years post-implant, of which one was untreated and the other was treated with additional device placement. Of 13 patients reported with stent kinking, compression or deformation, six were converted to open surgical repair and the remainder treated endovascularly. Of 18 reports of Type IIIB endoleak, one occurred procedurally and 15 occurred post-procedurally out to five years. Treatment included conversion to open repair (2) or additional device placement to reline the device (15), and one patient in stable condition will continue to be monitored.

AFX: Three stent fractures were reported in proximal extension stent grafts between the index procedure and 18 months post-implant, all of which were treated with an additional device. A total of 25 patients were reported with stent kinking [10] or compression/deformation [15], five of which were converted to open surgical repair with the remaining 20 patients treated endovascularly. Reports of Type IIIB endoleak have largely been associated with the bifurcated device, but have been reported to a lesser extent in proximal extensions. There have been no reports of Type IIIB endoleak associated with limb extensions. A total of thirty-nine [39] events occurred procedurally to within 1 year post-implant, forty-three [43] events were identified within 1-2 years post-implant, thirty-five [35] events occurred between 2-3 years post-implant, and fourteen [14] events were identified beyond 3 years post-implant. Among these cases, five deaths were reported; the remainder were treated with open surgical conversion (23) or secondary endovascular intervention using additional stent grafts to reline the original implant (102). Procedural factors such as guidewire/catheter manipulation or aggressive balloon molding were associated with a percentage of reports. Other contributing factors include use in off-label or highly calcified anatomy, lateral movement and changes in implant stability (also associated with Type IIIA endoleak), implant of other manufacturer’s thoracic devices as proximal extensions, and use of an excessively large aortic extension relative to the bifurcated device body (e.g. a 34mm proximal extension placed with a 25mm bifurcated device body).

An IFU update and retraining was performed in mid-2014 to reinforce precautions to avoid damage to the graft cover, with emphasis on post-deployment stent graft balloon molding and guidewire/catheter manipulation, in addition to device selection and sizing recommendations aimed at improving device stability. Post-market surveillance evaluation since retraining has shown a reduction (~20%) in reports of AFX Type IIIB endoleak. Additionally, Endologix continues to closely monitor the incidence of Type IIIB endoleaks occurring after implementation of the Duraply graft process change and have shown ~80% reduction in reported events since implementation in late 2014. Finally, IFU updates and retraining have included reinforcement of patient adherence to post-operative imaging follow-up, as well as clarifying imaging technique/modality guidelines for use in monitoring.

Commercial Experience Summary

From all reports received by Endologix, the worldwide commercial experience to date demonstrates that

the Powerlink and AFX Systems continue to perform as safe and effective endovascular stent graft treatments

of abdominal aortic aneurysms in appropriately selected patients, consistent with the clinical study experience.

Cumulative experience reinforces the appropriateness of adherence to the approved instructions for use in

ensuring consistent outcomes procedurally and post-procedurally.


MM1059 Rev 01 31

SECTION 3: Device Explant Evaluations Endologix monitors product performance to ensure the ongoing quality, safety, and efficacy of its products.

When a stent graft implanted during the US studies and during commercial experience is explanted from a

patient and returned for evaluation, an investigation is performed, including a thorough review of the product

manufacturing records, original implant and patient clinical and follow-up imaging records provided, clinician-

provided explant observations and reports, and engineering evaluation of the returned stent graft using

standard techniques, including x-ray and scanning electron microscopy. Independent gross and

histopathological evaluations of explanted stent grafts are performed by a board certified pathologist to

assess biologic response as well as device integrity.

Table 23 summarizes the reasons for explant reported in clinical studies and commercial experience. A total

of 13 patients enrolled in the US clinical studies have undergone conversion to open repair and device explant.

A total of 288 conversions to open repair were reported in the 66,000 bifurcated devices implanted. As of

October 31, 2015, Endologix has received 76 explanted devices from US (N=68) and international (N=8)

commercial experience. Of these, 15 (20%) were within 30 days; the remaining 61 explants occurred between

33 days and seven years after the original implant. The mean time to explant was 16 months. The primary

cause of explant is unresolved endoleak.

Table 23. Reasons for Device Explants

Reason for Explant Clinical Studies (726 Implants)

Commercial Devices

Aneurysm Rupture 0 6

Aneurysm Sac Expansion 0 1

Device Compression 0 6

Endoleak (including failed secondary intervention)¥ 6 25

Infection 0 4

Graft Suture Break or Graft Hole/Tear£ 0 12

Migration or Lateral Movement 0 5

Occlusion 0 12

Unrelated death (autopsy/device retrieval) 2 0

Other* 5 5

Total 13 76

*Other includes explant at initial implant; expanding thoracic aneurysm; unspecified endoleak; physician modification of device; failed repair of surgical graft.

¥Stent Observations: In eight explants, wire breaks identified were determined to have likely occurred during the explant procedure. No

stent corrosion, fractures, or twists were observed in any explant.

£Graft Observations: Graft tears, suture breaks or stent graft modifications leading to graft tears or holes were evaluated for all

explanted devices. Graft tears or cuts in seven explants were determined to have likely occurred at the time of the explant procedure. Six explants (four intact aneurysms, two ruptured aneurysms) identified a graft tear or hole in a device. Four bifurcated devices had graft holes located at or near the bifurcated device body-limb suture connection, of which one was attributed to physician modification of the graft material prior to original implant; cause of the remaining holes are unknown. Graft holes found near the suture line in two proximal extension devices were potentially attributed to procedural ballooning.

Investigations and explant evaluations identified no manufacturing issues. Clinician explant reports identified

no aortic wall injuries or abnormalities caused by the device.


MM1059 Rev 01 32

SECTION 4: Notes to Clinicians

Patient Selection, Device Selection, and Follow-up Recommendations

The 17Fr AFX Introducer System may be introduced via either iliac artery. Common femoral artery access and

aneurysm sac orientation are considerations. If one iliac artery is more tortuous, aneurysmal or diseased, the

other side may be considered preferable for delivery catheter access allowing for easier manipulation and

control. Access vessel diameter and morphology (e.g., tortuosity, occlusive disease, presence of thrombus

and/or calcification) should be compatible with vascular access techniques and the profile of the delivery

systems. Vessels that are significantly calcified, occlusive, tortuous or thrombus-lined may preclude placement

of the endovascular graft and/or may increase the risk of embolization. The patency of at least one internal

iliac artery should be maintained to reduce the risk of pelvic/bowel ischemia.

Key anatomic elements that may affect successful exclusion of the aneurysm include severe proximal neck

angulation, short proximal aortic neck seal zone, irregular calcification and/or plaque. It is also reported in the

literature that aortic tortuosity and larger aneurysm size may result in progressive, long-term displacement of

an endograft mid-section toward the aneurysm wall, thus elevating the risk of the junctional leaks and

disconnections even in previously well-excluded aneurysms. Endologix recommends that physicians plan for

maximum overlap of stent graft components, particularly in large or long aneurysms. In cases where adequate

overlap cannot be achieved through a two piece configuration, placement of a third (bridging) piece should be

considered.

The following determinants should be considered in selecting devices during pre-implant planning: Angulation of the infrarenal aortic neck and iliac arteries Quality of the aortic neck Diameter of the infrarenal aortic neck Diameter of the aneurysm and aortic tortuosity Length from the most caudal renal artery to the aortic bifurcation Length from the aortic bifurcation to the distal seal zone and/or internal iliac arteries Aneurysm(s) extending into the iliac arteries may require special consideration in selecting a suitable

graft/artery interface site Diameter of the external and common iliac arteries Pre-dilation of the iliac arteries may ease the deployment procedure in tortuous/calcified iliac anatomy

All lengths and diameters of the stent grafts necessary to complete the procedure should be available to the

physician, especially when pre-operative case planning measurements (treatment diameters/lengths) are not

certain. This approach allows for greater intraoperative flexibility to achieve optimal procedural outcomes.

Under sizing or over sizing may result in incomplete sealing or compromised flow. As shown in the clinical studies,

the long main body of the anatomically-fixed bifurcated stent graft provides columnar strength and foundational

support for the implant. Care should be taken to select the bifurcated device with the longest body length

suitable for the patient’s anatomy without compromising luminal blood flow. When accessory stent grafts are

used to complete the repair, pre-procedure planning and device selection should aim to maximize overlap with

the primary bifurcated stent graft. In patients with angulated aortic necks, very large diameter aneurysms,

tortuous aortas, or long renal to bifurcation lengths, the use of an additional infrarenal proximal extension

component may offer additional support to the initial bifurcated body-proximal extension stent graft junction.


MM1059 Rev 01 33

Endologix recommends that the AFX stent graft component diameters be selected as described in the

Instructions for Use (IFU) and that the stent graft diameter be at least 2mm larger than the normal aortic inner

diameter (e.g., a 25mm diameter stent graft should not be deployed in a normal aortic inner diameter >23mm).

The length of the graft-covered portion of the AFX stent graft implant should extend from the lowest renal artery

to the common iliac artery sealzone location, ensuring preservation of at least one internal iliac artery.

Note that the 34mm proximal extensions are indicated for use only with the 28mm bifurcated stent grafts. The

safety and effectiveness of the 34mm proximal extensions implanted with the 22mm or 25mm bifurcated stent

grafts have not been established. Endologix does not recommend the use of the 34mm stent graft with 22 or

25mm bifurcated stent grafts.

Continued monitoring and follow-up of patients treated with the device for endovascular stent grafts is

essential. All patients should be advised that endovascular treatment requires life-long, regular follow-up to

assess their health and the performance of their endovascular graft is a critical part of ensuring the ongoing

safety and effectiveness of endovascular treatment of AAAs. Patients should be counseled on the importance of

adhering to the follow-up schedule during the first year and at yearly intervals thereafter, and that subsequent

reintervention including catheter based and open surgical conversion are possible following endograft

placement.

Physicians should evaluate patients on an individual basis and prescribe their follow-up relative to the needs and

circumstances of each individual patient. At a minimum, Endologix recommends that high resolution CT scan

(contrast-enhanced and non-contrast) imaging follow-up to be performed at one month, six months, one year,

and annually thereafter for examination of:

Device integrity (e.g., absence of stent fracture or graft holes/tear);

Maintained overlap between bifurcated and extension stent grafts;

Absence of clinically relevant migration or lateral movement;

Aneurysm enlargement, perigraft flow, loss of patency, increased tortuosity, or progressive disease.

Duplex ultrasound may be used for those patients experiencing renal failure, who are otherwise unable to

undergo contrast enhanced CT scan, or at physician discretion. Plain x-rays may provide information on stent

integrity and maintained component overlap.

Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms, changes in the structure or

position of the endovascular graft, or reduced overlap of stent graft components) should receive more

frequent follow-up.

If Type I or III endoleak is present, prompt intervention and additional follow-up post-intervention is

recommended. The physician-defined schedule for patient follow-up should be maintained even in the absence

of clinical symptoms (e.g., pain, numbness, weakness).


MM1059 Rev 01 34

More frequent/additional surveillance and possible treatment is recommended for:

Aneurysms with Type I or III endoleaks

Aneurysm enlargement, 5mm in maximum diameter (regardless of endoleak status or type)

Migration or lateral displacement of the implant

Inadequate seal length (proximally or distally)

Reduction in stent graft component overlap since the first post-operative exam

Stent graft compression or kinking, or narrowing of a stent graft limb

When making a decision regarding reintervention or conversion to open repair, you should consider the

individual patient’s co-morbidities, life expectancy and the patient’s personal choices. Additional endovascular

intervention (e.g., additional component placement) or conversion to open surgical repair following initial

endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease

in sealzone length (proximal or distal), reduction in component overlap (e.g., separation or impending separation

of the bifurcated stent graft body from the extension stent graft) and/or endoleak. An increase in aneurysm size

and/or persistent endoleak may lead to aneurysm rupture. Patients experiencing reduced blood flow through

the graft limb and/or endoleaks may be required to undergo secondary interventions or surgical procedures.

Federal Law (US) requires that all AAA stent grafts be tracked (per 21 CFR 821). That tracking includes a

Patient Implant Card to be given to the patient upon release from the institution and a Device Tracking Form

to be mailed or faxed back to the manufacturer.

Product Additions, Enhancements, and Improvements Information on the performance of the Endologix stent graft design and implant technique has been received

during controlled clinical study use, from early post-market physician training experience, during emergency

use in patients who might not otherwise be treatable using another endovascular option, and from the more

widespread commercial experience in the US and internationally. In addition, input for improvement

opportunities has been obtained from focused physician groups.

In controlled clinical experience, it is evident that the prevention of distal migration or lateral movement and

the associated sequelae is essential to ensuring long-term, sustained performance of any endovascular stent

graft. In each associated clinical study described in this report, implantation of the bifurcated device on the

aortic bifurcation with the long main body across the aneurysm, with achieved proximal seal has resulted in

prevention of aneurysm rupture and inhibition of movement or migration. To allow for use of the device in

patients with different length aortic and iliac anatomies, more bifurcated and extension stent graft options

were introduced. In addition, to address the patient population with larger iliac artery anatomy, flared and

stepped limb extensions were introduced.

Published literature suggests that different patient anatomies and/or conditions may suggest preferential


MM1059 Rev 01 35

device orientation (i.e., suprarenal vs. infrarenal placement).7,8,9

Suprarenal orientation may be preferred in

shorter, more angulated, thrombus-lined, or irregularly shaped infrarenal necks. Conversely, infrarenal placement may be preferred in patients with renal stent placement or renal artery stenosis, and in patients with long or tapered proximal infrarenal necks, where the radial force imparted by the proximal edge of the

stent graft can be most effective. It may also be preferred in patients having competing angles in the infrarenal

and suprarenal aorta, where suprarenal placement may result in incomplete device apposition. To provide a complete treatment offering to physicians and their patients, the company introduced stent grafts in both infrarenal and suprarenal configuration to accommodate physician requirements in treating their patients.

Endologix treatment options facilitate endovascular repair in patients with proximal aortic necks between

18mm and 32mm in diameter, with device availability in both infrarenal and suprarenal configuration. Limb

extensions in a variety of configurations and with flexibility as needed for the specific anatomy accommodate

common iliac artery seal zones up to 23mm in diameter.

The delivery system has been improved iteratively following the initial US commercial experience to increase

flexibility and maneuverability and to further facilitate use in challenging anatomy. In addition, the delivery

system was improved by incorporating a snarable tip into the pre-cannulated contralateral limb assembly. This

feature facilitates contralateral limb placement compatible with standard percutaneous 9Fr introducer sheath

access.

In pursuing continuous improvement and in a concerted effort to be responsive to physician feedback, the

company developed, obtained FDA approval, and introduced the 17Fr AFX Introducer System and a wide

array of AFX bifurcated and accessory stent grafts. All AFX stent graft delivery systems are compatible with

the AFX 17Fr Introducer System. This expanded offering enables physicians to achieve low profile access and

to tailor the endovascular repair to each patient's unique anatomy.

Bifurcated stent grafts with 20mm diameter limbs were made available to treat patients with common iliac

arteries 14 to 18mm in diameter. Low outer profile 14Fr and 16Fr limb extension delivery systems have been

made available that do not require an introducer sheath, but are compatible with the AFX Introducer System

if so desired. The Vela™ Proximal Endograft System was made available in early 2014. This system is compatible with the

AFX Introducer System, and includes a proximal extension stent graft having a radiopaque marker in the

proximal edge for visual clarity of the graft line under fluoroscopy. The delivery system is designed with an

integrated release sleeve for controlled delivery of the proximal extension at the target implant location. In 2014, Endologix developed and commercialized an improved ePTFE graft using proprietary processing

methods which results in a high-density, multi-layered material referred to as DURAPLY™. This improvement

increases the graft material strength while preserving the material’s favorable biocompatibility profile, strength,

and other conformability and mechanical characteristics.

7 Carpenter JP, Baum RA, Barker CF, et al. Impact of exclusion criteria on patient selection for endovascular abdominal aortic

aneurysm repair. J Vasc Surg 2001;34:1050-1054. 8 Gitlitz DB, Ramaswami G, Kaplan D, et al. Endovascular stent grafting in the presence of aortic neck filling defects: early clinical

experience. J Vasc Surg 2001;33:340-4. 9 Marin ML, Parsons RE, Hollier LH, et al. Impact of transrenal aortic endograft placement on endovascular graft repair of

abdominal aortic aneurysms. J Vasc Surg 1998;26:638-46.


MM1059 Rev 01 36

Enhancements have been made to the AFX Instructions for Use (IFU) throughout the products commercial

history. In 2015, the AFX IFU was updated to further clarify existing information related to procedure planning

and follow-up imaging, and to improve the instructions for Vela deployment and delivery system withdrawal.

Updates focused mainly on factors related to Type III endoleak prevention and monitoring; strengthening

warnings/precautions, clarifying patient selection/treatment approach, and recommendations for imaging and

post-operative patient follow-up. In addition, the IFU was amended to further emphasize the importance of

selecting the longest bifurcated main body and longest proximal extension length to maximize overlap

between components, as well as the use of an additional infrarenal extension to enhance overlap in patients

with an angulated aortic neck, tortuous aorta, large diameter aneurysm, long renal to bifurcation length, or as

deemed appropriate. The imaging guidelines section was updated to include factors specific to Type III

endoleak identification, including reduction in overlap and device integrity verification.

To study AFX outcomes in commercial use, Endologix initiated a new study in 2015, entitled, “Looking at EVAR

Outcomes by Primary Analysis of Randomized Data” - the LEOPARD Study. It is the first multicenter,

prospective, randomized study of endovascular abdominal aortic aneurysm repair (EVAR) in the US and will

randomize 800 patients 1:1 to AFX or another commercially available stent graft, and follow patients at pre-

specified timepoints for safety and performance-related outcomes. To date, 58 sites are open for enrollment

and 167 patients have been randomized into the study. Study results will be included in future clinical updates.

The AFX2 Bifurcated Endograft System is FDA and CE Mark approved. AFX2 consists of a new delivery system

that features an integrated 0.035” contralateral wire to replace the previous 0.014” wire, refinement of the

hemostatic control within the handle, and reduction of the contralateral introducer from 9F to a 7F profile.

The inclusion of a contralateral .035" wire eliminates the previous contralateral wire exchange reducing both

the number and complexity of steps in deployment. AFX2 is expected to be introduced in the U.S. and

international markets in 2016.


MM1059 Rev 01 37

SECTION 5: Brief Summary of Indications, Warnings and Precautions from IFU

The Endologix bifurcated stent grafts and extension stent graft accessories are intended for endovascular

treatment in patients with AAA. In 2013, an expanded indication including bilateral percutaneous access

was approved by the US FDA. As outlined in the IFU, factors that are critical for a successful endovascular

repair include the following:

Appropriate patient selection for this endograft, including:

o Adequate iliac/femoral artery access

o Adequate proximal aortic neck sealzone (≥18 to ≤32mm diameter; ≥15mm length; a n d ≤60° angle

to the aneurysm sac)

o Adequate common iliac artery sealzones (≥10 to ≤23mm diameter; ≥15mm length; ≤90° angle to

the aortic bifurcation)

Device selection for the patient according to the IFU

Device delivery and deployment according to the IFU

Continued patient follow-up and imaging on a timely basis

Imaging surveillance at an increased frequency for patients with specific clinical findings (e.g., endoleaks,

enlarging aneurysms, or changes in the structure or position of the stent graft, including reduced overlap

of stent graft components)

The AFX Endovascular AAA System was evaluated using Endologix components. The safety and effectiveness of

other stent or stent graft devices used in conjunction with the AFX System have not been established.

The devices are contraindicated in patients who have a condition that threatens to infect the stent graft, or

in patients with sensitivities or allergies to the device materials.

Adverse Event Reporting

Any adverse event (clinical incident) involving the AFX Endovascular AAA System should be reported to

Endologix, Inc. immediately. To report an incident, call the Customer Service Department at 800-983-2284 (24

hours message service). Outside the US, contact your local Endologix representative.

Potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to: amputation, anesthetic complications and subsequent attendant problems (e.g., aspiration), aneurysm enlargement, aneurysm rupture and death, aortic damage, including perforation, dissection, bleeding, rupture and death, arterial or venous thrombosis and/or pseudoaneurysm, arteriovenous fistula, bleeding, hematoma or coagulopathy, bowel complications (e.g., ileus, transient ischemia, infarction, necrosis), cardiac complications and subsequent attendant problems (e.g., arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension), claudication (e.g., buttock, lower limb), death, edema, embolization (micro and macro) with transient or permanent ischemia or infarction, endoleak, stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture and perigraft flow, fever and localized inflammation, genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence, hematuria, infection), hepatic failure, impotence, infection of the aneurysm, device access site, including abscess formation, transient fever and pain, lymphatic complications and subsequent attendant problems (e.g., lymph fistula), neurologic local or systemic complications and subsequent attendant problems (e.g., stroke, transient ischemic attack, paraplegia, paraparesis, paralysis), occlusion of device or native vessel, pulmonary/respiratory complications and subsequent attendant problems (e.g., pneumonia, respiratory failure, prolonged intubation), renal complications and subsequent attendant


MM1059 Rev 01 38

problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure), surgical conversion to open repair, vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, vessel damage, wound complications and subsequent attendant problems (e.g., dehiscence, infection), vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death).

Warnings and Precautions

Read all instructions carefully. Failure to properly follow the IFU or to observe the warnings and precautions

may lead to serious consequences or injury to the patient. The device should only be used by physicians

and teams trained in vascular interventional techniques and in the use of this specific device. Always have a

vascular surgery team available during implantation or reintervention procedures in the event that conversion

to open surgical repair is necessary. The device is for single use only; do not reuse the device.

Patient Selection, Treatment, and Follow-up

The Endologix devices have not been evaluated in some patient populations, including those <18 years of age,

pregnant or nursing females, with mycotic aneurysms, traumatic aortic injury, uncorrectable coagulopathy,

indispensable mesenteric artery, leaking, pending rupture or ruptured aneurysms, revision of previously placed

endovascular grafts, pseudoaneurysms resulting from previous graft placement, genetic connective tissue

disease (e.g., Marfan’s or Ehlers-Danlos’ Syndromes), concomitant thoracic aortic or thoracoabdominal

aneurysms, or patients with active systemic infections. Key anatomic elements that may affect successful

exclusion of the aneurysm include severe proximal neck angulation (>60° between the infrarenal neck to axis

to the aneurysm body); irregular and/or short proximal aortic neck (<15 mm); thrombus and/or calcium at the

arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface. Irregular

calcification and/or plaque may compromise graft integrity or the fixation and sealing of the implantation sites.

Necks exhibiting these key anatomic elements may be more conducive to graft migration. The Endologix

endografts are not recommended in patients who cannot tolerate contrast agents necessary for intraoperative

and post-operative follow-up imaging. Refer to the IFU for all warnings and precautions. An overview is

provided below: Catheter advancement should be performed under fluoroscopic guidance.

Take care during manipulation of catheters, wires and sheaths within an aneurysm. Significant disturbances may

dislodge fragments of thrombus which can cause distal embolization.

Inaccurate placement, inadequate fixation and/or incomplete sealing of the stent graft within the vessel may result

in increased risk of endoleak, migration or inadvertent occlusion of the renal or internal iliac arteries. Renal artery

patency must be maintained to prevent/reduce the risk of renal failure and subsequent complications.

Select the bifurcated body to achieve seal within the proximal neck, or to land no more than 2cm below the distal

neck. When placing a proximal extension stent graft, select the longest extension device suitable for the patient to

achieve significant overlap with the bifurcated stent graft body.

When placing a limb extension stent graft, overlap with the bifurcated stent graft limb must be at least 20mm.

Care should be taken not to damage the stent graft or disturb positioning after graft placement. Incorrect

deployment or migration of the stent graft may require surgical intervention.

When ballooning the stent graft, there is an increased risk of vessel injury and/or rupture, and possible patient

death, if the balloon is not completely within the ePTFE graft covered portion of the stent graft. Over-inflation of a

balloon beyond the nominal diameter of the stent graft may result in damage to the vessel wall and/or vessel

rupture, or damage to the stent graft.

Additional endovascular intervention or conversion to open surgical repair following initial endovascular

repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation

length (including reduction in component overlap) and/or endoleak. An increase in aneurysm size and/or

persistent endoleak may lead to aneurysm rupture. Patients experiencing reduced blood flow through the

graft limb and/or endoleaks may be required to undergo secondary interventions or surgical procedures.


MM1059 Rev 01 39

The Endologix endovascular stent graft design and associated endovascular repair outcomes in clinical

studies and observational studies involving both standard risk and complex anatomies have been published

and support the approved labeling.10,11,12,13,1415,16,17,18,19,20,21,22,23,24,25,26,27

10 Carpenter JP and the Endologix Investigators. Midterm results of the multicenter trial of the Powerlink bifurcated system for

endovascular aortic aneurysm repair. J Vasc Surg 2004;40:849-59.

11 Albertini JN, Lahlou Z, Magnan PE, et al. Endovascular repair of abdominal aortic aneurysms with a unibody stent-graft: 3-year

results of the French Powerlink multicenter trial. J Endovasc Ther 2005;12:629-37.

12 Lifeline Registry Publication Committee. Lifeline registry of endovascular aneurysm repair: long-term primary outcome measures. J

Vasc Surg 2005;42:1-10.

13 Parmer S and Carpenter JP. Endovascular aneurysm repair with suprarenal or infrarenal fixation: study of renal effects. J Vasc Surg 2006;43:19-25.

14 Sicard GA, Zwolak RM, Sidaway AN, etal. Endovascular abdominal aortic aneurysm repair: long-term outcome measures in patients at

high risk for open repair. J Vasc Surg 2006;44:229-36.

15 Qu L, Hetzel G and Raithel D. Seven years’ single center experience of Powerlink unibody bifurcated endograft for endovascular aortic

aneurysm repair. J Cardiovasc Surg 2007;48:13-19.

16 Wang G and Carpenter J. The Powerlink System for endovascular aortic abdominal aneurysm repair: six year results. J Vasc Surg 2008;48:535-45.

17 Coppi G, Silingardi R, Tasselli S, et al. Endovascular treatment of abdominal aneurysms with the Powerlink endograft graft: influence

of placement on the bifurcation and use of a proximal extension in early and late outcomes. J Vasc Surg 2008;795-801.

18 Wang G and Carpenter JP. EVAR in small vs. large aneurysms: does size influence outcome? Vasc Endovascular Surg 2009;43:244-51.

19 Jordan WD Jr, Moore WM Jr, Melton JG, Brown OW, and Carpenter JP. Secure fixation following EVAR with the Powerlink XL

system in wide aortic necks: results of a prospective, multicenter trial. J Vasc Surg 2009;50:979-86.

20 Harlin SA, Beasley RE, Feldman RL, et al. Endovascular AAA repair using an anatomical fixation technique and concomitant

suprarenal orientation: results of a prospective, multicenter trial. Ann Vasc Surg 2010;24:921-9.

21 Carpenter JP, Garcia MJ, Harlin SA, et al. Contemporary results of Endovascular repair of abdominal aortic aneurysms: effect of

anatomical fixation on outcomes. J Endovasc Ther 2010;17:153-62.

22 Patel M and Carpenter JP. The value of the initial post-EVAR computed tomography angiography scan in predicting future secondary procedures with the Powerlink stent graft. J Vasc Surg 2010;52(5):1135-9.

23 Kracjer Z, Nelson PR, Bianchi C, et al. Percutaneous endovascular abdominal aortic aneurysm repair: methods and initial outcomes

from the first prospective, multicenter trial. J Cardiothorac Surg 2011;52:651-9.

24 Nelson PR, Krajcer Z, Kansal N, et al. A multicenter, randomized, controlled trial of totally percutaneous access versus open

femoral exposure for endovascular aortic aneurysm repair. J Vasc Surg 2014;59:1181-94.

25 Welborn MB III, McDaniel HB, Johnson RC, et al. Clinical outcome of an extended proximal seal zone with the AFX endovascular aortic aneurysm system. J Vasc Surg 2014;60:876-83.

26 Melas N, Stavridis K, Saratzis A, Lazarides J, Gitas C, Saratzis N. Active proximal sealing in the endovascular repair of abdominal aortic

aneurysms: early results with a new stent-graft. J Endovasc Ther. 2015;22(2):174-178.

27 Skibba A a., Evans JR, Greenfield DT, et al. Management of late main-body aortic endograft component uncoupling and type IIIa

endoleak encountered with the Endologix Powerlink and AFX platforms. J Vasc Surg. 2015;i:1-8.

2015 Clinical Update - Choose Your Region - Endologix · Endologix, Inc. Powerlink System and AFX...

Documents

Transcript of 2015 Clinical Update - Choose Your Region - Endologix · Endologix, Inc. Powerlink System and AFX...