VASCULAR
hamburger
product photo

The Supera Peripheral Stent System is a unique class of technology that allows the Supera stent to mimic the anatomy's natural movement and is an effective option for the dynamic environment of the SFA and popliteal arteries. Supera is clinically proven, demonstrating excellent patency in the SUPERB trial and has been analyzed in over 1,600 patients worldwide in the SUPERB trial and 13 retrospective studies1.

INTERWOVEN STENT DESIGN

The Supera stent mimics the natural structure and movement of the anatomy. The innovative, interwoven nitinol design creates a stent that supports rather than resists the vessel.2 By pre-dilating and matching the stent and vessel 1:1, Supera stent supports the vessel with minimal chronic outward force.5,6

STRENGTH AND FLEXIBILITY

Supera stent has unparalleled strength and flexibility, with more than four times the compression resistance of all other standard nitinol stents.3,7 In severely calcified lesions, Supera stent has visible compression resistance, maintaining a round, open lumen for normal, healthy blood flow in challenging anatomy.2

CLINICALLY PROVEN4

  • 86.3% primary patency (K-M) at 1 year
  • 87.6% freedom from TLR in severe calcium at 3 years
  • 0 fracture at 1 year

 

1. 1,636 patients studied, see Werner, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding nitinol stent: midterm results for the Leipzig SUPERA 500 registry, EuroIntervention 2014:10:861-868. (including Leipzig SFA, Leipzig Popliteal and S500 LL), 439 patients; Goverde, et al., AURORRA registry: Experience with high radial force interwoven nitinol stents in femoropopliteal arteries, LINC 2013, 117 patients; Molenaar, et al., Interwoven self-expanding nitinol stents for long complex SFA and popliteal lesions CWZ, LINC 2012, 178 patients; Goltz, et al., Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients with Critical Limb Ischemia, J Endovasc Ther 2012;19:450-456, 40 patients; Chan, et al., Primary stenting of femoropopliteal atherosclerotic lesions using new helical interwoven nitinol stents, JVS Feb 2014:59:384-391, 78 patients; Pacanowski, et al., RESTORE: Interwoven Stents in the Real World, The Initial United States Experience with the Use of the Supera Stent in the SFA and Popliteal Artery, LINC 2013, 147 patients; George , et al., SUPERA interwoven nitinol Stent Outcomes in Above-Knee Interventions (SAKE) study, JVIR 25.6: 954-61, 80 patients; Dumantepe, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm results, Vascular February 2015, 36 patients; Varcoe, R., A Real World Experience Using SUPERA in Long, Challenging Lesions, LINC 2015, 105 patients; Brescia, et al., Stenting of femoropopliteal lesions using interwoven nitinol stents, J Vasc Surg. 2015 Mar 6, 38 patients; Mussa, et al., The SUPERA stent for superficial femoral artery lesions even with calcification, Charing Cross 2015, 41 patients; Lojedo Vicent, et al., Experiencia inicial en la colocacion de endoprotesis Supera en eltratmiento de la patologia arterial en sector femoropopliteo , XIV Congreso de la SERVEI 2015, 29 patients; Palena, et al., SUPERSUB Trial: 1-yr outcomes of Supera Subinitimal stenting in CLI patents, LINC 2016, 34 patients; Rosenfield, K., et al., Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries 12 Month Results of the SUPERB Trial, Circ Cardiovasc Interv. 2015, 264 patients.
2. Characteristically round lumens supported by Arena, F.J., Arena, F.A. Intravascular Ultrasound Evaluation of Interwoven Nitinol Stents at Implant. J Vasc Med Surg. 2013:1;116.
3. Strength is defined as compression resistance The compression resistance for a 5.0 x 100 mm Supera implant is 9 kg at 53% compression. This is four times the compression resistance of all other competitors. All other products compressed 53% with less than 2.25 kg applied. Data on file at Abbott Vascular
4. Garcia L., et al., Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries 12 Month Results of the SUPERB Trial, Circ Cardiovasc Interv. 2015
5. Supera Peripheral Stent System Instructions for Use
6. Measurements taken at upper limit of labeled vessel diameter mm. Data on file at Abbott Vascular
7. Flexibility is defined as kink resistance measured in a tube. The Supera sizes with the lowest kink resistance, as compared to 6.0 x 100 mm standard nitinol stents, are the 5.0 x 100 and 6.0 x 100 mm implants. Data on file at Abbott Vascular

SUPERA STENT — CLINICAL DATA

SUPERA STENT IS CLINICALLY PROVEN AND WIDELY STUDIED

The Supera Stent has been widely studied with over 1,600 patients worldwide in the SUPERB trial and 13 retrospective studies. In all the studies, Supera stent showed durable results with zero fractures at one year1. In the SUPERB Study (FDA Approval Study), Supera stent demonstrated 86.3% primary patency (K-M) at one year and 90.5% primary patency when nominally deployed2,3. The three year freedom from targeted lesion revascularization (TLR) was 83% and 94% when nominally deployed3. Overall, Supera stent is clinically proven with excellent long-term outcomes.

Supera Clinical Data

1. 1,636 patients studied, see Werner, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding nitinol stent: midterm results for the Leipzig SUPERA 500 registry, EuroIntervention 2014:10:861-868. (including Leipzig SFA, Leipzig Popliteal and S500 LL), 439 patients; Goverde, et al., AURORRA registry: Experience with high radial force interwoven nitinol stents in femoropopliteal arteries, LINC 2013, 117 patients; Molenaar, et al., Interwoven self-expanding nitinol stents for long complex SFA and popliteal lesions CWZ, LINC 2012, 178 patients; Goltz, et al., Endovascular Treatment of Popliteal Artery Segments P1 and P2 in Patients with Critical Limb Ischemia, J Endovasc Ther 2012;19:450-456, 40 patients; Chan, et al., Primary stenting of femoropopliteal atherosclerotic lesions using new helical interwoven nitinol stents, JVS Feb 2014:59:384-391, 78 patients; Pacanowski, et al., RESTORE: Interwoven Stents in the Real World, The Initial United States Experience with the Use of the Supera Stent in the SFA and Popliteal Artery, LINC 2013, 147 patients; George , et al., SUPERA interwoven nitinol Stent Outcomes in Above-Knee Interventions (SAKE) study, JVIR 25.6: 954-61, 80 patients; Dumantepe, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm results, Vascular February 2015, 36 patients; Varcoe, R., A Real World Experience Using SUPERA in Long, Challenging Lesions, LINC 2015, 105 patients; Brescia, et al., Stenting of femoropopliteal lesions using interwoven nitinol stents, J Vasc Surg. 2015 Mar 6, 38 patients; Mussa, et al., The SUPERA stent for superficial femoral artery lesions even with calcification, Charing Cross 2015, 41 patients; Lojedo Vicent, et al., Experiencia inicial en la colocacion de endoprotesis Supera en eltratmiento de la patologia arterial en sector femoropopliteo , XIV Congreso de la SERVEI 2015, 29 patients; Palena, et al., SUPERSUB Trial: 1-yr outcomes of Supera Subinitimal stenting in CLI patents, LINC 2016, 34 patients; Rosenfield, K., et al., Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries 12 Month Results of the SUPERB Trial, Circ Cardiovasc Interv. 2015, 264 patients.
2. Garcia L., et al., Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries 12 Month Results of the SUPERB Trial, Circ Cardiovasc Interv. 2015
3. Supera Peripheral Stent US Instructions for Use – nominal analysis was a non-powered post hoc analysis

SUPERA STENT — SUPERB TRIAL

SUPERB STUDY OVERVIEW (FDA APPROVAL STUDY)

The SUPERB trial was a prospective, multi-center, single-arm study with core lab adjudication performed in the U.S. The trial enrolled 264 patients who received the Supera stent. The primary efficacy endpoint was vessel patency at 12 months with a peak systolic velocity ratio (PSVR) of ≥ 2.0 measured by duplex ultrasound.

DESIGN

  • Supera implant patency compared to VIVA OPG1
  • 264 subjects (ITT) – 34 sites; 36 month follow up
  • HCRI data coordinating center, CEC & DSMB, Vascore duplex ultrasound and X-Ray core laboratory, and BIDMC angiographic core laboratory

PRIMARY SAETY ENDPOINT

  • Composite of all death, TLR or any amputation of index limb to 30 (± 7) days

PRIMARY EFFICACY ENDPOINT

  • Vessel patency at 12 months (Primary patency is defined by peak systolic velocity ratio < 2.0 per Duplex ultrasound and no target lesion revascularization)

SUPERB TRIAL PATIENT CHARACTERISTICS2

  • The SUPERB trial evaluated patients with peripheral artery disease with the majority of patients having a Rutherford 3 classification with severe claudication.

supera-superb-trial-patient-characteristics-int

SUPERB TRIAL LESION CHARACTERISTICS2

The majority of patients who were enrolled in the SUPERB trial had lesions which were located in the Mid SFA (54%) and had severe calcification (45%). The average lesion length was 78 mm (range 8.5 mm – 236 mm)3

supera-superb-trial-lesion-int

1. Rocha-Singh K., Performance Goals and Endpoint Assessments, Catheterization and Cardiovascular Interventions 69:910–919 (2007)
2. Garcia L., et al., Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries 12 Month Results of the SUPERB Trial, Circ Cardiovasc Interv. 2015
3. Supera Peripheral Stent US Instructions for Use

SUPERA STENT — PATENCY AND TLR

HIGH PATENCY RATES AT 1-YEAR WITH SUPERA

With proper sizing, vessel preparation, and deployment technique, Supera stent provides excellent patency rates as shown in the SUPERB trial. When nominal stent length deployment (± 10%) is achieved, a higher primary patency of 90.5% was reported, compared to the overall 86.3% in the trial.1

1 Year Primary Patency (K-M)

supera-stent-patency-int

LOW RE-INTERVENTION RATE WITH SUPERA AT 3 YEARS

The SUPERB trial demonstrated strong results with 94% freedom from target lesion revascularization (TLR) at 3 years when Supera stent was deployed nominally. The data also showed a minimal change in freedom from TLR from one year to three years.1

Freedom From TLR at 1,2, and 3 Years

supera-stent-tlr-int

EXCELLENT OUTCOMES TO STANDARD NITINOL STENTS

Supera’s freedom from TLR outperforms other standard nitinol stents at three years, and when the Supera stent is deployed at its nominal stent length, the results show an even greater improvement.

Freedom From TLR at 1,2, and 3 Years

supera-stent-tlr-3-years-int

Data differences depicted between these trials may not be statistically significant or clinically meaningful and different clinical trials may include differences in the demographics of the patient populations.


1. Supera Peripheral Stent US Instructions for Use – nominal analysis was a non-powered post hoc analysis
2. STROLL 1-year, G. Ansel, LINC 2013; 2-year, W. Gray ISET 2013. 3-year, M Jaff ISET 2014
3. Laird, J. Journal of Endovascular Therapy 2012;19:1–9
4. DURABILITY II, K Rocha-Singh, VIVA 13; M Razavi ISET 2014.

SUPERA STENT — LONG LESIONS

SUPERA DEMONSTRATES CONSISTENT RESULTS ACROSS LESION LENGTHS

A sub-group analysis of the SUPERB trial results separated into three lesion lengths groups (shortest, middle and longest lesions) demonstrated no drop in restenosis rates at one year freedom from restenosis rates between short lesions (mean 35.4 mm) and long lesions (mean 126 mm).24

Percent of Lesions without Restenosis by Lesion Length

(12 months SUPERB TRIAL)

Supera Superb Trial Lesion Length

SUPERB DATA EVEN IN LONG LESIONS

The chart below displays 1 year primary patency across multiple SFA trials by lesion length. Data from PTA, Standard Nitinol Stents and Supera Stent trials were included. In the PTA and Standard Nitinol Stent studies, a clear steady decline in patency was observed as lesion length increased. Supera stent patency across lesion lengths follows a different trend line as noted by the three key publication results.

Consistent Supera data across lesion lengths in comparison to SES and PTA

12-Month Data Across SFA Trials by Lesion Length

supera-lesion-length-comparison-int

CONSISTENT 1 YEAR PRIMARY PATENCY ACROSS PUBLISHED LESION LENGTH*

The results of 1 year primary patency from published studies that included details on lesion length and patency is charted below. The published average lesion lengths ranged from 5.8 cm to 24.0 cm. Supera stent trial results noted consistent 1 year primary patency results regardless of lesion length.

Published 1 year Patency Across Lesion Lengths

supera-lesion-length-patency-int

*Published data was included if lesion length and patency were both available.
**Stent length
Data differences depicted between these trials may not be statistically significant or clinically meaningful and different clinical trials may include differences in the demographics of the patient populations.


1. SUPERB: Garcia L., et al., Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries 12 Month Results of the SUPERB Trial, Circ Cardiovasc Interv. 2015.
2. SUPERA 500: Werner, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding nitinol stent: midterm results for the Leipzig SUPERA 500 registry, EuroIntervention 2014:10:861-868.
3. SUPERA 500 LL: Werner, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding nitinol stent: midterm results for the Leipzig SUPERA 500 registry, EuroIntervention 2014:10:861-868.
4. COMPLETE SE: IFU, Complete SE.
5. Belgian ABSOLUTE: Schroe, H. Absolute BELGIAN study. CIRCE 2008.
6. ZILVER PTX IFU/SSED.
7. RESILIENT: IFU, LifeStent.
8. STROLL: Ansel, G. STROLL Trial. LINC 2013.
9. ZILVER PTX (BMS arm): Dake, M.D., Ansel, G.M., Jaff, M.R., et al. Paclitaxel-Eluting Stents Show Superiority to Balloon Angioplasty and Bare Metal Stents in Femoropopliteal Disease: Twelve-Month Zilver PTX Randomized Study Results. Circ Cardiovasc Interv. 2011:4(5):495–504.
10. DURABILITY II: Everflex Instructions for Use.
11. DURABILITY I: Bosiers, M., Torsello, G., Gissler, H.M., et al. Nitinol Stent Implantation in Long Superficial Femoral Artery Lesions: 12-Month Results of the DURABILITY I Study. J Endovasc Ther. 2009;16(3):261–269.
12. DURABILITY 200: Bosiers, M. Durability 200 Study. LINC 2011.
13. Vienna ABSOLUTE: Schillinger, M., Sabeti, S., Loewe, C., et al. Balloon Angioplasty Versus Implantation of Nitinol Stents in the Superficial Femoral Artery. N Engl J Med. 2006;354(18):1879–1888.
14. VIBRANT (BMS): Ansel, G. One-year interim results: Gore VIBRANT clinical study. LINC 2010.
15. Rocha-Singh, K.J., Jaff, M.R., Crabtree, T.R., Bloch, D.A., Ansel, G.; VIVA Physicians, Inc. Performance Goals and Endpoint Assessments for Clinical Trials of Femoropopliteal Bare Nitinol Stents in Patients with Symptomatic Peripheral Arterial Disease. Catheter Cardiovasc Interv. 2007;69(6):910–919.
16. Scheinert, D., Werner, M., Scheinert, et al. Treatment of Complex Atherosclerotic Popliteal Artery Disease with a New Self-Expanding Interwoven Nitinol Stent: 12-Month Results of the Leipzig SUPERA Popliteal Artery Stent Registry. JACC Cardiovasc Interv. 2013;6(1):65–71
17. Scheinert, D., Grummt, L., Piorkowski, M. A Novel Self-Expanding Interwoven Nitinol Stent for Complex Femoropopliteal Lesions: 24-Month Results of the SUPERA SFA Registry. J Endovasc Ther. 2011;18(6):745–752
18. Dumantepe, et al., Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm results, Vascular 2015
19. Leon, L.R. Jr., Dieter, R.S., Gadd, C.L., et al. Preliminary Results of the Initial United States Experience with the Supera Woven Nitinol Stent in the Popliteal.
20. Chan, Y.C., Cheng, S.W., Ting, A.C., Cheung, G.C., Primary Stenting of Femoropopliteal Atherosclerotic Lesions Using New Helical Interwoven Nitinol Stents. J Vasc Surg. 2014; 59(2):384–391.
21. George , et al., SUPERA interwoven nitinol Stent Outcomes in Above-Knee IntErventions (SAKE) study, JVIR 25.6: 954-615.
22. Myint M, Schouten O, Varcoe R. et al. A Real-World Experience with the Supera Interwoven Niitinol Stent in Femoropopliteal Arteries: Midterm Patency Results and Failure Analysis. J Endovasc Ther 2016:1-9.
23. Brescia, et al., Stenting of femoropopliteal lesions using interwoven nitinol stents, J Vasc Surg. 2015 Mar 6. pii: S0741-5214(15)00132-9
24. Walker C. SUPERB Trial Data: A Vasculomimetic Stent is the Treatment of Choice for Highly Calcific Long SFA Disease. NCVH 20
15 

SUPERA STENT — SEVERE CALCIFICATION

SUPERA HAS STRONG OUTCOMES IN SEVERELY CALCIFIED LESIONS

In the SUPERB trial, 45% of lesions were severely calcified, which represented a large sub-group of high-risk patients. Despite the challenging and complex lesions, Supera stent was able to demonstrate 89% primary patency (VIVA) at one year in this sub-group. Freedom from targeted lesion revascularization (TLR) for this same group was 95% at one year and 88% at three years.1

supera-suberb-trial-knee-int

FREEDOM FROM TLR% OVER TIME IN SEVERE CALCIUM

supera-fredom-from-tlr-int

SUPERB DATA

supera-superb-data-int

1. Garcia , L et al. The SUPERB Trial: 3 year results, VIVA 2014

SUPERA STENT — SUPERA VS DRUG COATED BALLOONS AND STANDARD NITINOL STENTS

SUPERA OUTPERFORMS DRUG COATED BALLOONS AND STANDARD NITINOL STENTS1

Dr. Sabine Steiner and the Leipzig, Germany team conducted a retrospective analysis (propensity matched) on their large database of patients undergoing fem-pop interventions. Published results from this analysis provide a comparison of patency rates up to 40 months on Supera vs DCB and Supera vs BMS. Supera outperformed BMS and DCB in this real world patient population.

supera-analysis-intMidterm Patency After Femoropopliteal Interventions: A Comparison of Standard and Interwoven Nitinol Stents and Drug-Coated Balloons in a Single-Center, Propensity Score-Matched Analysis

Steiner S, Schmidt A, Bausback Y , et al. JEVT 2016, Vol 23(2) 347-355

Propensity data analysis completed to reduce selection bias from clinical  and lesion characteristics.

Based on real-world patients undergoing femoropopliteal treatment with DCB, BMS or Supera at a single institution.

Key assessment: Primary patency up to 40 months using duplex ultra-sound and/or angiography.

supera-outcomes-int

Data differences depicted between these trials may not be statistically significant or clinically meaningful and different clinical trials may include differences in the demographics of the patient populations.


1. Steiner S, Schmidt A, Bausback Y , et al. Midterm Patency After Femoropopliteal Interventions: A Comparison of Standard and Interwoven Nitinol Stents and Drug-Coated Balloons in a Single-Center, Propensity Score-Matched Analysis. JEVT 2016, Vol 23(2) 347-355

SUPERA STENT — LESION PREPARATION

LESION PREPARATION FOR SUPERB OUTCOMES

Per the Instructions for Use, prepare the vessel utilizing standard angioplasty technique using a balloon size greater than or equal to the outer stent diameter.

Pre-Dilatation Sizing Table

supera-pre-dilate-sizing

 

Precaution: The vessel / duct after pre-dilatation should be at least the size of the stent diameter. If recommended vessel / duct diameter cannot be gained, optimal stent deployment may not be achieved and revised stent sizing should be considered.

supera-stent-diameter-int

SUPERA STENT — ORDERING INFORMATION

6F 120CM

supera-stent-6f120cm

 

6F 80CM

supera-stent-6f80cm

 

 

AP2939381-WBO Rev. C

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?

true
accessibility
© 2016 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

YESNO
accessibility

You are about to exit the Abbott family of websites for a 3rd party website

Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott.


The website that you have requested also may not be optimized for your screen size.

Do you wish to continue and exit this website?

YESNO