CompleteSE Medtronic
6
Complete ™ SE Vascular SELF-EXPANDING STENT SYSTEM Innovating for life. Complete Performance CONTROL. COMMITMENT. CONFIDENCE. NOW APPROVED For SFA/PPA
description
CompleteSE Medtronic
Transcript of CompleteSE Medtronic
OPTIMISED CELL DESIGN FOR KINK RESISTANCE AND FLEXIBILITY*
Three different segment lengths allow consistent behavior across all diameters:
• Minimal foreshortening
• Excellent flexibility
Testing was performed with a flat-plate crush to 30% of labeled nominal stent diameter.
COMPLETE PERFORMANCESUPERIOR RADIAL FORCE WITHOUT SACRIFICING CONFORMABILITY*
Offset crown design minimises crown-to-crown interaction while bending
Tested in multimode conditions representative of the iliac, superficial femoral and proximal popliteal arteries to substantiate long-term performance
* Test data on file at Medtronic, Inc. Benchtop data may not be indicative of clinical performance.
Complete™ SE Vascular Product Code
Catheter Working Length Length (F = 80, L = 130)
Diameter Product Code
SC 6 20 LG
ORDER INFORMATION
Atraumatic tip
Retractable sheath
Dual-deployment handle
Radiopaque markers
Stabilizing sheath
Mea
n R
adia
l For
ce (N
)
6.0
5.0
4.0
3.0
2.0
1.0
0.0
4.61
CordisSmart®
Control®
RADIAL FORCE
MedtronicComplete
SE
5.46
BardLifeStent®
5.13
3.60
CookZilver®
635
MedtronicComplete
SE
4.15
BardLifeStent
2.69
4.55
CordisSmart
Control
MedtronicComplete
SE
5.16
AbbottAbsolute
Pro®
5.08
ev3Protégé®EverFlex®
3.62
7mm x 100 mm 8mm x 80 mm 8mm x 100 mm
UC
2013
0055
4 EE
© 2
013
Med
tron
ic, I
nc. A
ll rig
hts
rese
rved
. Not
for d
istr
ibut
ion
in th
e U
SA .
01/1
3
Complete™ SE Vascular SELF-EXPANDING STENT SYSTEM
Innovating for life.
Complete PerformanceCONTROL. COMMITMENT. CONFIDENCE.
NOW APPROVEDFor SFA/PPA
Stent Diameter
(mm)
Stent Length (mm) Minimum Sheath Size (F)
Catheter Working Length
(cm)20 30 40 60 80 100 120 150
4 SC420LG SC430LG SC440LG — — — — — 6 130
5 SC520LG SC530LG SC540LG SC560LG SC580LG SC5100LG SC5120LG SC5150LG 6 130
6 SC620LG — SC640LG SC660LG SC680LG SC6100LG SC6120LG SC6150LG 6 130
7 SC720LG — SC740LG SC760LG SC780LG SC7100LG SC7120LG SC7150LG 6 130
8 SC820LG — SC840LG SC860LG SC880LG SC8100LG SC8120LG SC8150LG 6 130
9 SC920LG — SC940LG SC960LG SC980LG — — — 6 130
10 SC1020LG — SC1040LG SC1060LG SC1080LG — — — 6 130
The Complete SE stent is MRI conditional. The Complete SE Vascular Self-Expanding Stent System is indicated to improve luminal diameter in symptomatic patients with previously unstented iliac stenosis in the common and external iliac arteries or atherosclerotic lesions of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (PPA) with vessel reference diameters between 3.5 mm and 9.0 mm.
Warning: Please reference appropriate product Instructions for Use for a list of indications, warnings, precautions and potential adverse event
Stent Diameter
(mm)
Stent Length (mm) Minimum Sheath Size (F)
Catheter Working Length
(cm)20 30 40 60 80 100 120 150
4 SC420FG SC430FG SC440FG — — — — — 6 80
5 SC520FG SC530FG SC540FG SC560FG SC580FG SC5100FG SC5120FG SC5150FG 6 80
6 SC620FG — SC640FG SC660FG SC680FG SC6100FG SC6120FG SC6150FG 6 80
7 SC720FG — SC740FG SC760FG SC780FG SC7100FG SC7120FG SC7150FG 6 80
8 SC820FG — SC840FG SC860FG SC880FG SC8100FG SC8120FG SC8150FG 6 80
9 SC920FG — SC940FG SC960FG SC980FG — — — 6 80
10 SC1020FG — SC1040FG SC1060FG SC1080FG — — — 6 80
www.medtronicendovascular.com www.medtronic.eu
Invatec S.p.A. Via Martiri della Libertà 7 25030 Roncadelle (BS) ItalyTel: +39.030.2589311
INVATEC Technology Center GmbHHungerbüelstrasse 12a8500 FrauenfeldSwitzerlandTel: +41.52.2600660
Medtronic, Inc.710 Medtronic Parkway NEMinneapolis, MN 55432USATel: +1.763.514.4000
Medtronic International Trading SàrlRoute du Molliau 31 CH-1131 Tolochenaz Switzerland Tel: +41.21.802.7000
Medtronic of Canada Ltd. 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada Tel: +1.905.460.3800
Medtronic Latin America 3750 NW 87th Avenue, Suite 700 Miami, FL 33178 USA Tel: +1.786.709.4200
Medtronic International Ltd. 49 Changi South Avenue 2 Singapore 486056 Tel: +65.6436.5000
Medtronic Australasia Pty Ltd.97 Waterloo Road North Ryde, NSW 2113 Australia Tel: +61.29857.9000
Medtronic Korea Co., Ltd.5F, Sajo Building 1001 Daechi-dong, Kangnam-ku Seoul, 135-280 Korea Tel: +82.2.3404.3600
Medtronic Mediterranean S.A.L. St. Charles City Center 6th Floor, Omar Doauk Street Beirut 2020-0908 Lebanon Tel: +961.1.370670
COMPLETE CONTROLDEPLOYMENT AND ACCURACY MADE EASY
The Complete® SE 6 F delivery system’s unique design incorporates a dual
deployment handle and a triaxial catheter. The dual deployment handle is
intuitive and easy to use, giving you the ultimate control during deployment
while the triaxial catheter minimises unexpected jumping.*
1. Rotate the handle to retract the sheath slowly and allow the stent to expand in a precisely controlled manner.†
2. Once the stent is properly positioned, complete the deployment by simply pushing the buttons and pulling back the handle in one fluid motion.
Retractable sheath
Inner shaft
The stabilising sheath reduces friction and allows the retractable sheath to move back freely. This decreases the amount of force required to deploy the stent, making deployment easy and accurate.
The delivery system’s triaxial design includes an inner shaft, a retractable sheath and a stabilising sheath.
COMPLETE COMMITMENTAPPROVED FOR ILIAC ARTERY, SFA AND PPA
Medtronic and physicians alike are committed to improving patients’ lives. We pursue
this mission, in part, by arming healthcare providers with clinical data they need to
practice evidence-centered medicine. Complete® SE embodies this commitment with
continued follow-up in clinical trials that capture the device’s safety and efficacy in the
iliac, superficial femoral and proximal popliteal arteries.
* Compared with SFA studies of Cook Zilver PTX, IDEV SUPERA, Cordis Smart Stent, Bard Lifestent and EV3 Protégé Everflex.
† Rocha-Singh K et al. Catheter Cardiovasc Interv. 2007;69:910-919.†† Reference Complete SE SFA Study - Clinically Driven TLR rate.1Independently adjudicated by core lab.2Lesions as reported by the Angiographic Core Laboratory.3Based on number of lesions with available data.
PATIENT DEMOGRAPHICS N = 196 %
Age 68.7 ± 10.5
Male 63.3
Diabetes mellitus 45.4
Dyslipidemia 79.6
Hypertension 90.3
History of tobacco use 79.6
History of CAD 62.8
History of COPD 21.4
Previous MI 26.2
LESION MORPHOLOGY1 % (m/n)3
Total lesion length (n = 213)2 (mm) 60.7 ± 37.62
Total occlusion 29.9 (60/201)
Distal SFA/PPA 49.7 (106/213)
Mid SFA 34.3 (73/213)
Proximal SFA 16.0 (34/213)
Calcification
Severe 56.2 (118/210)
Moderate 34.8 (73/210)
None/mild 9.0 (19/210)
BINARY TRIAL ENDPOINT †† %
MAE at 12 months 11.0
TVR 11.0
TLR 8.4
PRIMARY EFFICACY ENDPOINT
Primary patency (PSVR < 2.0) 72.6
Dual Deployment Handle*
Triaxial Catheter
COMPLETE CONFIDENCEFEWEST REINTERVENTIONS IN THE SFA*
An independently adjudicated single-arm multicenter trial evaluated
the performance of Complete® SE for the treatment of atherosclerotic
lesions of the superficial femoral and proximal popliteal arteries. A
representative population comprised of 196 subjects was enrolled
with results compared with VIVA Performance Goals.†
Complete SE Iliac Registry Complete SE SFA Study
2002 2005 2011
ISIS-SE Study
12-month MAE 3.3%TVR 2.1%TLR 2.1%(n = 158)
9-month MAE 9.4%TVR 9.4%TLR 3.8%(n = 55)
12-month MAE 11.0%TVR 11.0%TLR 8.4%(n = 196)
* Test data on file at Medtronic, Inc. Benchtop data may not be indicative of clinical performance.† Data on file
8.4%at 12 months††
TLR rate
COMPLETE CONTROLDEPLOYMENT AND ACCURACY MADE EASY
The Complete® SE 6 F delivery system’s unique design incorporates a dual
deployment handle and a triaxial catheter. The dual deployment handle is
intuitive and easy to use, giving you the ultimate control during deployment
while the triaxial catheter minimises unexpected jumping.*
1. Rotate the handle to retract the sheath slowly and allow the stent to expand in a precisely controlled manner.†
2. Once the stent is properly positioned, complete the deployment by simply pushing the buttons and pulling back the handle in one fluid motion.
Retractable sheath
Inner shaft
The stabilising sheath reduces friction and allows the retractable sheath to move back freely. This decreases the amount of force required to deploy the stent, making deployment easy and accurate.
The delivery system’s triaxial design includes an inner shaft, a retractable sheath and a stabilising sheath.
COMPLETE COMMITMENTAPPROVED FOR ILIAC ARTERY, SFA AND PPA
Medtronic and physicians alike are committed to improving patients’ lives. We pursue
this mission, in part, by arming healthcare providers with clinical data they need to
practice evidence-centered medicine. Complete® SE embodies this commitment with
continued follow-up in clinical trials that capture the device’s safety and efficacy in the
iliac, superficial femoral and proximal popliteal arteries.
* Compared with SFA studies of Cook Zilver PTX, IDEV SUPERA, Cordis Smart Stent, Bard Lifestent and EV3 Protégé Everflex.
† Rocha-Singh K et al. Catheter Cardiovasc Interv. 2007;69:910-919.†† Reference Complete SE SFA Study - Clinically Driven TLR rate.1Independently adjudicated by core lab.2Lesions as reported by the Angiographic Core Laboratory.3Based on number of lesions with available data.
PATIENT DEMOGRAPHICS N = 196 %
Age 68.7 ± 10.5
Male 63.3
Diabetes mellitus 45.4
Dyslipidemia 79.6
Hypertension 90.3
History of tobacco use 79.6
History of CAD 62.8
History of COPD 21.4
Previous MI 26.2
LESION MORPHOLOGY1 % (m/n)3
Total lesion length (n = 213)2 (mm) 60.7 ± 37.62
Total occlusion 29.9 (60/201)
Distal SFA/PPA 49.7 (106/213)
Mid SFA 34.3 (73/213)
Proximal SFA 16.0 (34/213)
Calcification
Severe 56.2 (118/210)
Moderate 34.8 (73/210)
None/mild 9.0 (19/210)
BINARY TRIAL ENDPOINT †† %
MAE at 12 months 11.0
TVR 11.0
TLR 8.4
PRIMARY EFFICACY ENDPOINT
Primary patency (PSVR < 2.0) 72.6
Dual Deployment Handle*
Triaxial Catheter
COMPLETE CONFIDENCEFEWEST REINTERVENTIONS IN THE SFA*
An independently adjudicated single-arm multicenter trial evaluated
the performance of Complete® SE for the treatment of atherosclerotic
lesions of the superficial femoral and proximal popliteal arteries. A
representative population comprised of 196 subjects was enrolled
with results compared with VIVA Performance Goals.†
Complete SE Iliac Registry Complete SE SFA Study
2002 2005 2011
ISIS-SE Study
12-month MAE 3.3%TVR 2.1%TLR 2.1%(n = 158)
9-month MAE 9.4%TVR 9.4%TLR 3.8%(n = 55)
12-month MAE 11.0%TVR 11.0%TLR 8.4%(n = 196)
* Test data on file at Medtronic, Inc. Benchtop data may not be indicative of clinical performance.† Data on file
8.4%at 12 months††
TLR rate
COMPLETE CONTROLDEPLOYMENT AND ACCURACY MADE EASY
The Complete® SE 6 F delivery system’s unique design incorporates a dual
deployment handle and a triaxial catheter. The dual deployment handle is
intuitive and easy to use, giving you the ultimate control during deployment
while the triaxial catheter minimises unexpected jumping.*
1. Rotate the handle to retract the sheath slowly and allow the stent to expand in a precisely controlled manner.†
2. Once the stent is properly positioned, complete the deployment by simply pushing the buttons and pulling back the handle in one fluid motion.
Retractable sheath
Inner shaft
The stabilising sheath reduces friction and allows the retractable sheath to move back freely. This decreases the amount of force required to deploy the stent, making deployment easy and accurate.
The delivery system’s triaxial design includes an inner shaft, a retractable sheath and a stabilising sheath.
COMPLETE COMMITMENTAPPROVED FOR ILIAC ARTERY, SFA AND PPA
Medtronic and physicians alike are committed to improving patients’ lives. We pursue
this mission, in part, by arming healthcare providers with clinical data they need to
practice evidence-centered medicine. Complete® SE embodies this commitment with
continued follow-up in clinical trials that capture the device’s safety and efficacy in the
iliac, superficial femoral and proximal popliteal arteries.
* Compared with SFA studies of Cook Zilver PTX, IDEV SUPERA, Cordis Smart Stent, Bard Lifestent and EV3 Protégé Everflex.
† Rocha-Singh K et al. Catheter Cardiovasc Interv. 2007;69:910-919.†† Reference Complete SE SFA Study - Clinically Driven TLR rate.1Independently adjudicated by core lab.2Lesions as reported by the Angiographic Core Laboratory.3Based on number of lesions with available data.
PATIENT DEMOGRAPHICS N = 196 %
Age 68.7 ± 10.5
Male 63.3
Diabetes mellitus 45.4
Dyslipidemia 79.6
Hypertension 90.3
History of tobacco use 79.6
History of CAD 62.8
History of COPD 21.4
Previous MI 26.2
LESION MORPHOLOGY1 % (m/n)3
Total lesion length (n = 213)2 (mm) 60.7 ± 37.62
Total occlusion 29.9 (60/201)
Distal SFA/PPA 49.7 (106/213)
Mid SFA 34.3 (73/213)
Proximal SFA 16.0 (34/213)
Calcification
Severe 56.2 (118/210)
Moderate 34.8 (73/210)
None/mild 9.0 (19/210)
BINARY TRIAL ENDPOINT †† %
MAE at 12 months 11.0
TVR 11.0
TLR 8.4
PRIMARY EFFICACY ENDPOINT
Primary patency (PSVR < 2.0) 72.6
Dual Deployment Handle*
Triaxial Catheter
COMPLETE CONFIDENCEFEWEST REINTERVENTIONS IN THE SFA*
An independently adjudicated single-arm multicenter trial evaluated
the performance of Complete® SE for the treatment of atherosclerotic
lesions of the superficial femoral and proximal popliteal arteries. A
representative population comprised of 196 subjects was enrolled
with results compared with VIVA Performance Goals.†
Complete SE Iliac Registry Complete SE SFA Study
2002 2005 2011
ISIS-SE Study
12-month MAE 3.3%TVR 2.1%TLR 2.1%(n = 158)
9-month MAE 9.4%TVR 9.4%TLR 3.8%(n = 55)
12-month MAE 11.0%TVR 11.0%TLR 8.4%(n = 196)
* Test data on file at Medtronic, Inc. Benchtop data may not be indicative of clinical performance.† Data on file
8.4%at 12 months††
TLR rate
OPTIMISED CELL DESIGN FOR KINK RESISTANCE AND FLEXIBILITY*
Three different segment lengths allow consistent behavior across all diameters:
• Minimal foreshortening
• Excellent flexibility
Testing was performed with a flat-plate crush to 30% of labeled nominal stent diameter.
COMPLETE PERFORMANCESUPERIOR RADIAL FORCE WITHOUT SACRIFICING CONFORMABILITY*
Offset crown design minimises crown-to-crown interaction while bending
Tested in multimode conditions representative of the iliac, superficial femoral and proximal popliteal arteries to substantiate long-term performance
* Test data on file at Medtronic, Inc. Benchtop data may not be indicative of clinical performance.
Complete™ SE Vascular Product Code
Catheter Working Length Length (F = 80, L = 130)
Diameter Product Code
SC 6 20 LG
ORDER INFORMATION
Atraumatic tip
Retractable sheath
Dual-deployment handle
Radiopaque markers
Stabilizing sheath
Mea
n R
adia
l For
ce (N
)
6.0
5.0
4.0
3.0
2.0
1.0
0.0
4.61
CordisSmart®
Control®
RADIAL FORCE
MedtronicComplete
SE
5.46
BardLifeStent®
5.13
3.60
CookZilver®
635
MedtronicComplete
SE
4.15
BardLifeStent
2.69
4.55
CordisSmart
Control
MedtronicComplete
SE
5.16
AbbottAbsolute
Pro®
5.08
ev3Protégé®EverFlex®
3.62
7mm x 100 mm 8mm x 80 mm 8mm x 100 mm
UC
2013
0055
4 EE
© 2
013
Med
tron
ic, I
nc. A
ll rig
hts
rese
rved
. Not
for d
istr
ibut
ion
in th
e U
SA .
01/1
3
Complete™ SE Vascular SELF-EXPANDING STENT SYSTEM
Innovating for life.
Complete PerformanceCONTROL. COMMITMENT. CONFIDENCE.
NOW APPROVEDFor SFA/PPA
Stent Diameter
(mm)
Stent Length (mm) Minimum Sheath Size (F)
Catheter Working Length
(cm)20 30 40 60 80 100 120 150
4 SC420LG SC430LG SC440LG — — — — — 6 130
5 SC520LG SC530LG SC540LG SC560LG SC580LG SC5100LG SC5120LG SC5150LG 6 130
6 SC620LG — SC640LG SC660LG SC680LG SC6100LG SC6120LG SC6150LG 6 130
7 SC720LG — SC740LG SC760LG SC780LG SC7100LG SC7120LG SC7150LG 6 130
8 SC820LG — SC840LG SC860LG SC880LG SC8100LG SC8120LG SC8150LG 6 130
9 SC920LG — SC940LG SC960LG SC980LG — — — 6 130
10 SC1020LG — SC1040LG SC1060LG SC1080LG — — — 6 130
The Complete SE stent is MRI conditional. The Complete SE Vascular Self-Expanding Stent System is indicated to improve luminal diameter in symptomatic patients with previously unstented iliac stenosis in the common and external iliac arteries or atherosclerotic lesions of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (PPA) with vessel reference diameters between 3.5 mm and 9.0 mm.
Warning: Please reference appropriate product Instructions for Use for a list of indications, warnings, precautions and potential adverse event
Stent Diameter
(mm)
Stent Length (mm) Minimum Sheath Size (F)
Catheter Working Length
(cm)20 30 40 60 80 100 120 150
4 SC420FG SC430FG SC440FG — — — — — 6 80
5 SC520FG SC530FG SC540FG SC560FG SC580FG SC5100FG SC5120FG SC5150FG 6 80
6 SC620FG — SC640FG SC660FG SC680FG SC6100FG SC6120FG SC6150FG 6 80
7 SC720FG — SC740FG SC760FG SC780FG SC7100FG SC7120FG SC7150FG 6 80
8 SC820FG — SC840FG SC860FG SC880FG SC8100FG SC8120FG SC8150FG 6 80
9 SC920FG — SC940FG SC960FG SC980FG — — — 6 80
10 SC1020FG — SC1040FG SC1060FG SC1080FG — — — 6 80
www.medtronicendovascular.com www.medtronic.eu
Invatec S.p.A. Via Martiri della Libertà 7 25030 Roncadelle (BS) ItalyTel: +39.030.2589311
INVATEC Technology Center GmbHHungerbüelstrasse 12a8500 FrauenfeldSwitzerlandTel: +41.52.2600660
Medtronic, Inc.710 Medtronic Parkway NEMinneapolis, MN 55432USATel: +1.763.514.4000
Medtronic International Trading SàrlRoute du Molliau 31 CH-1131 Tolochenaz Switzerland Tel: +41.21.802.7000
Medtronic of Canada Ltd. 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada Tel: +1.905.460.3800
Medtronic Latin America 3750 NW 87th Avenue, Suite 700 Miami, FL 33178 USA Tel: +1.786.709.4200
Medtronic International Ltd. 49 Changi South Avenue 2 Singapore 486056 Tel: +65.6436.5000
Medtronic Australasia Pty Ltd.97 Waterloo Road North Ryde, NSW 2113 Australia Tel: +61.29857.9000
Medtronic Korea Co., Ltd.5F, Sajo Building 1001 Daechi-dong, Kangnam-ku Seoul, 135-280 Korea Tel: +82.2.3404.3600
Medtronic Mediterranean S.A.L. St. Charles City Center 6th Floor, Omar Doauk Street Beirut 2020-0908 Lebanon Tel: +961.1.370670
OPTIMISED CELL DESIGN FOR KINK RESISTANCE AND FLEXIBILITY*
Three different segment lengths allow consistent behavior across all diameters:
• Minimal foreshortening
• Excellent flexibility
Testing was performed with a flat-plate crush to 30% of labeled nominal stent diameter.
COMPLETE PERFORMANCESUPERIOR RADIAL FORCE WITHOUT SACRIFICING CONFORMABILITY*
Offset crown design minimises crown-to-crown interaction while bending
Tested in multimode conditions representative of the iliac, superficial femoral and proximal popliteal arteries to substantiate long-term performance
* Test data on file at Medtronic, Inc. Benchtop data may not be indicative of clinical performance.
Complete™ SE Vascular Product Code
Catheter Working Length Length (F = 80, L = 130)
Diameter Product Code
SC 6 20 LG
ORDER INFORMATION
Atraumatic tip
Retractable sheath
Dual-deployment handle
Radiopaque markers
Stabilizing sheath
Mea
n R
adia
l For
ce (N
)
6.0
5.0
4.0
3.0
2.0
1.0
0.0
4.61
CordisSmart®
Control®
RADIAL FORCE
MedtronicComplete
SE
5.46
BardLifeStent®
5.13
3.60
CookZilver®
635
MedtronicComplete
SE
4.15
BardLifeStent
2.69
4.55
CordisSmart
Control
MedtronicComplete
SE
5.16
AbbottAbsolute
Pro®
5.08
ev3Protégé®EverFlex®
3.62
7mm x 100 mm 8mm x 80 mm 8mm x 100 mm
UC
2013
0055
4 EE
© 2
013
Med
tron
ic, I
nc. A
ll rig
hts
rese
rved
. Not
for d
istr
ibut
ion
in th
e U
SA .
01/1
3
Complete™ SE Vascular SELF-EXPANDING STENT SYSTEM
Innovating for life.
Complete PerformanceCONTROL. COMMITMENT. CONFIDENCE.
NOW APPROVEDFor SFA/PPA
Stent Diameter
(mm)
Stent Length (mm) Minimum Sheath Size (F)
Catheter Working Length
(cm)20 30 40 60 80 100 120 150
4 SC420LG SC430LG SC440LG — — — — — 6 130
5 SC520LG SC530LG SC540LG SC560LG SC580LG SC5100LG SC5120LG SC5150LG 6 130
6 SC620LG — SC640LG SC660LG SC680LG SC6100LG SC6120LG SC6150LG 6 130
7 SC720LG — SC740LG SC760LG SC780LG SC7100LG SC7120LG SC7150LG 6 130
8 SC820LG — SC840LG SC860LG SC880LG SC8100LG SC8120LG SC8150LG 6 130
9 SC920LG — SC940LG SC960LG SC980LG — — — 6 130
10 SC1020LG — SC1040LG SC1060LG SC1080LG — — — 6 130
The Complete SE stent is MRI conditional. The Complete SE Vascular Self-Expanding Stent System is indicated to improve luminal diameter in symptomatic patients with previously unstented iliac stenosis in the common and external iliac arteries or atherosclerotic lesions of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (PPA) with vessel reference diameters between 3.5 mm and 9.0 mm.
Warning: Please reference appropriate product Instructions for Use for a list of indications, warnings, precautions and potential adverse event
Stent Diameter
(mm)
Stent Length (mm) Minimum Sheath Size (F)
Catheter Working Length
(cm)20 30 40 60 80 100 120 150
4 SC420FG SC430FG SC440FG — — — — — 6 80
5 SC520FG SC530FG SC540FG SC560FG SC580FG SC5100FG SC5120FG SC5150FG 6 80
6 SC620FG — SC640FG SC660FG SC680FG SC6100FG SC6120FG SC6150FG 6 80
7 SC720FG — SC740FG SC760FG SC780FG SC7100FG SC7120FG SC7150FG 6 80
8 SC820FG — SC840FG SC860FG SC880FG SC8100FG SC8120FG SC8150FG 6 80
9 SC920FG — SC940FG SC960FG SC980FG — — — 6 80
10 SC1020FG — SC1040FG SC1060FG SC1080FG — — — 6 80
www.medtronicendovascular.com www.medtronic.eu
Invatec S.p.A. Via Martiri della Libertà 7 25030 Roncadelle (BS) ItalyTel: +39.030.2589311
INVATEC Technology Center GmbHHungerbüelstrasse 12a8500 FrauenfeldSwitzerlandTel: +41.52.2600660
Medtronic, Inc.710 Medtronic Parkway NEMinneapolis, MN 55432USATel: +1.763.514.4000
Medtronic International Trading SàrlRoute du Molliau 31 CH-1131 Tolochenaz Switzerland Tel: +41.21.802.7000
Medtronic of Canada Ltd. 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada Tel: +1.905.460.3800
Medtronic Latin America 3750 NW 87th Avenue, Suite 700 Miami, FL 33178 USA Tel: +1.786.709.4200
Medtronic International Ltd. 49 Changi South Avenue 2 Singapore 486056 Tel: +65.6436.5000
Medtronic Australasia Pty Ltd.97 Waterloo Road North Ryde, NSW 2113 Australia Tel: +61.29857.9000
Medtronic Korea Co., Ltd.5F, Sajo Building 1001 Daechi-dong, Kangnam-ku Seoul, 135-280 Korea Tel: +82.2.3404.3600
Medtronic Mediterranean S.A.L. St. Charles City Center 6th Floor, Omar Doauk Street Beirut 2020-0908 Lebanon Tel: +961.1.370670
