Stellarex™ Drug-coated 0.035" Angioplasty Balloon

The Clear DCB

Choice

Featuring EnduraCoat™ Technology

Top-tier outcomes with the lowest

therapeutic drug dose in all patients– common to

complex

89.0%

patency2

IN COMMON PATIENT POPULATIONS

82.3%

patency1

IN HIGHLY COMPLEX PATIENTS

The Stellarex Difference.EnduraCoat™ Technology

Hybrid Paclitaxel

PEGExcipient

Top-TierClinical

Outcomes

Efficient Drug Transfer + Effective Tissue Residency + High Coating Durability + Minimal Particulate Loss

+ =

Stellarex delivers top-tier outcomes in more highly complex lesions and patient comorbidities than any DCB RCT—like the patients you see every day.

27.7%

Highly Complex Patients

Severe Calcium Diabetic Renal Insufficiency(*Renal Failure)

Clinically Obese Female0%

25%

30%

5%

35%

10%

40%

15%

45%

20%

50%

43.9%

12.7% 8.1%

10.4%

49.5%

37.4% 40.5%

43.4%

24.8%

39.5%

34.8%

18.0%

9.0% 8.3% 3.5%*

In.Pact [IN.PACT SFA]3

Lutonix [LEVANT 2]4StellarexILLUMENATE PIVOTAL1

ILLUMENATE EU RCT2

% O

F PAT

IENT

S

+ 89% primary patency in common patients with similar characteristics1

+ 82.3% patency in a complex patient population with the highest reported rate of

severe calcium

+ The only commercially available DCB with two reported randomized controlled trials

Stellarex has the highest patency rate of any DCB in a randomized controlled trial,

with up to 43% less drug load.

Top-Tier Patency

Data overview for informational purposes only and not for head-to-head comparison. Calcium definitions may vary from study to study, and the rates presented here are based on those used and reported in each respective study.

43%

HIGHEST PRIMARY PATENCY IN SIMILAR

PATIENTS WITH UP TO

LESS DRUGLOAD1,3

Choose Efficacy.

ILLUMENATE PIVOTAL1 N=200

ILLUMENATE EU RCT2 N=222

COMMON PATIENTS – SIMILAR CHARACTERISTICS

IN.PACT SFA3

N=200

In.Pact™3.5 μg/mm2

Lutonix®2 μg/mm2

Stellarex2 μg/mm2

LEVANT 24 N=316

PRIM

ARY P

ATEN

CY R

ATE

73.5%

8.1% 12.7% 10.4%

0% 0%

25%

50%

75%

100%

89.0% 86.6%

SEVERE CA++SEVERE CA++

SEVERE CA++SE

VERE

CALC

IUM

50%

60%

40%

30%

20%

10%

82.3%

43.9% SEVERE CA++

COMPLEXPATIENTS

44.0%

27.9%

35.0% 38.9%

Competitor studies are independent clinical trials with different protocols and definitions. Therefore, they are not head-to-head comparisons, and data presented cannot be directly compared. Calcium definitions may vary from study to study, and the rates presented here are based on those used and reported in each respective study. Complex patients refers to high rates of severe calcium, diabetes and renal insufficiency. Primary patency based on Kaplan-Meier estimates.

+ Safe treatment for the patients you see

every day

+ Low CD-TLR rates in both Stellarex RCTs

+ Clinically proven effect

Consistently low clinically driven target

lesion revascularization rates demonstrate

the safety of Stellarex across common to

complex patients.

Low CD-TLR

CD-T

LR R

ATE

15%

10%

5%

20%

0%

Stellarex StellarexPTA PTA

7.9%

16.8% 16.7%

5.9%

Choose Safety.

ILLUMENATE EU RCT2ILLUMENATE PIVOTAL1

In a bench test, Stellarex demonstrates minimal particulate loss,5 reducing the risk of

downstream embolization. Stellarex coating stability enables low therapeutic drug dose.

Low Particulate Loss

1,946

9,183

3,297

NUM

BER O

F PAR

TICU

LATE

≥

10 um

/mm

2 (x10

0)

Stellarex In.Pact Lutonix

12

10

8

6

4

2

0

LESS PARTICULATE LOSS THAN IN.PACT

79%

"THE STELLAREX TECHNOLOGY IN ONE WORD, PREDICTABILITY—PREDICTABLE RESULTS, CLINICAL EFFICACY THAT’S SUSTAINED OVER TIME AND NO SAFETY CONCERNS.”

JUAN F. GRANADA, MD, FACC | CRF SKIRBALL CENTER FOR INNOVATION, ORANGEBURG, NY

2µg/mm2

LOW DRUG DOSE

Bench test may not be indicative of clinical results.

LESS PARTICULATE LOSS THAN LUTONIX

41%

To lower the likelihood of any potential—and potentially harmful— dose excess and

particulate downstream effect possibly resulting in a delay of wound healing, loss of

microcirculation and creation of aneurysms.

Why Low Dose Matters

CRYSTALLINE PACLITAXEL

AMORPHOUS PACLITAXEL

PEG

Stellarex with EnduraCoat Technology offers a critical balance of hybrid paclitaxel with

Polyethylene Glycol (PEG) excipient—to provide efficient drug transfer and effective tissue

residency with high coating durability and minimal particulate loss.

EnduraCoat™ Technology = Hybrid Paclitaxel + PEG

Stellarex EnduraCoat Technology under optical microscopy5

EASY-TO-REMOVE PROTECTIVE SHEATH

TREAT LONG LESIONS UP TO 180 mm

LONG CATHETER WORKING LENGTH OF 135 cm

HIGHEST RATED BALLOON PRESSURES

LOW DRUG DOSE OF 2 µg/mm2

Low tip profile (0.039") and high pushability facilitate

trackability and lesion crossing, even in challenging

anatomies and through previously deployed stents.

Exceptional Balloon Performance

The Stellarex Difference.

+ Hybrid formulation offers the advantages of coating durability and prompt drug availability

by the amorphous paclitaxel and the sustained tissue release of crystalline paclitaxel

+ PEG’s high molecular weight offers excellent adhesion, flexibility, elongation and elasticity6

for adaptability during balloon deformation such as flexion, torsion and compression

+ Exceptional durability during handling, tracking and inflation to prevent premature drug loss

+ PEG may limit the amount of drug washout in the presence of calcium due to its affinity to

HAp (hydroxyl apatite), the primary component of calcified atherosclerotic lesions7

Product Catalog Number

Sheath Size (Fr)

Balloon Diameter (mm)

Balloon Length (mm)

Shaft Length (cm)

Nominal Pressure (atm)

Rated Burst Pressure (atm)

AB035SX040040080 6 4 40 80 10 20

AB035SX040060080 6 4 60 80 10 20

AB035SX040080080 6 4 80 80 10 20

AB035SX040120080 6 4 120 80 10 20

AB035SX050040080 6 5 40 80 10 18

AB035SX050060080 6 5 60 80 10 18

AB035SX050080080 6 5 80 80 10 18

AB035SX050120080 6 5 120 80 10 16

AB035SX060040080 6 6 40 80 8 14

AB035SX060060080 6 6 60 80 8 14

AB035SX060080080 6 6 80 80 8 14

AB035SX060120080 6 6 120 80 8 12

AB035SX040040135 6 4 40 135 10 20

AB035SX040060135 6 4 60 135 10 20

AB035SX040080135 6 4 80 135 10 20

AB035SX040120135 6 4 120 135 10 20

AB035SX050040135 6 5 40 135 10 18

AB035SX050060135 6 5 60 135 10 18

AB035SX050080135 6 5 80 135 10 18

AB035SX050120135 6 5 120 135 10 16

AB035SX060040135 6 6 40 135 8 14

AB035SX060060135 6 6 60 135 8 14

AB035SX060080135 6 6 80 135 8 14

AB035SX060120135 6 6 120 135 8 12

Corporate HeadquartersThe Spectranetics Corporation, 9965 Federal Drive, Colorado Springs, CO 80921Tel: 719-447-2000 | Fax: 719-447-2022 | Customer Service: 800-231-0978

©2017 Spectranetics. All rights reserved. Approved for external distribution. D036084-04 072017

Stellarex 0.035" OTW Drug-coated Angioplasty Balloon

Learn more and come visit us at www.stellarexdcb.com

References1 Lyden S. Oral presentation. ILLUMENATE Pivotal Stellarex DCB IDE Study 12-Month Results. TCT 2016. Washington D.C. November 2, 2016.2 Schroeder H, et al. Circulation 2017; 135:2227-2236.3 Jaff M. Drug-coated Balloon Treatment for Patients with Intermittent Claudication: Insights from the In.Pact Global Full Clinical Cohort. Oral Presentation at: VIVA 2016; September 19-22, 2016; Las Vegas, NV. In.Pact summary of safety and effectiveness data (SSED).

4 Rosenfield K., Jaff MR, White CJ, et al. NEJM 2015; 373:145-53. Lutonix Summary of Safety and Effectiveness Data (SSED). 5 Based on bench or animal studies. Data on file.6 Mark J, et al. Physical Properties of Polymers. Cambridge University Press. 3rd ed. 2004.7 Venkatasubbu GD, et al. Surface modification and paclitaxel drug delivery of folic acid modified polyethylene glycol functionalized hydroxyapatite nanoparticles. Powder Technology. 2013; 235:437-442.

Important Safety InformationThe Stellarex™ 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.

The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is contraindicated for use in:• Patients with known hypersensitivity to paclitaxel or structurally related compounds• Patients who cannot receive recommended antiplatelet and/or anticoagulation therapy• Women who are breastfeeding, pregnant or are intending to become pregnant, or men

intending to father children• Coronary arteries, renal arteries and supra-aortic/cerebrovascular arteries• Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon

or proper placement of the delivery system

Possible adverse effects associated with the balloon dilation procedure include, but are not limited to: Abrupt vessel closure; Allergic reaction to contrast medium, antiplatelet therapy

or catheter system components (drug, excipients and materials); Amputation/Loss of limb; Arrhythmias; Arterial aneurysm; Thrombosis; Arterio-venous fistula (AVF); Bleeding; Death; Embolism/Device embolism; Fever; Hematoma; Hemorrhage; Hypertension/Hypotension; Infection or pain at insertion site; Inflammation; Ischemia or infarction of tissue/organ; Occlusion; Pain or tenderness; Peripheral edema; Pseudoaneurysm; Renal insufficiency or failure; Restenosis; Sepsis or systemic infection; Shock; Stroke/Cerebrovascular accident; Vessel dissection, perforation, rupture, spasm or recoil; Vessel trauma that requires surgical repair; Balloon rupture; Detachment of a component of the balloon and/or catheter system; Failure of the balloon to perform as intended; Failure to cross the lesion.

Additional complications that may be associated with the addition of paclitaxel to the balloon include, but may not be limited to the following: Allergic/Immunologic reaction to paclitaxel; Alopecia; Anemia; Gastrointestinal symptoms (diarrhea, nausea, pain, vomiting); Hematologic dyscrasia (including neutropenia, leukopenia, thrombocytopenia); Hepatic enzyme changes; Histologic changes in vessel wall including inflammation, cellular damage or necrosis; Myalgia/Arthralgia; Myelosuppression; Peripheral neuropathy.

Efficient Drug Transfer + Effective Tissue Residency + High Coating Durability + Minimal Particulate Loss