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CARDIOVASCULAR
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Unmatched 1-Year Patency & 3-Year Freedom From TLR

The Supera™ Stent has been studied in over 2,000 patients worldwide in the SUPERB trial and 16 retrospective studies. Notably, in all of the 17 studies, the Supera™ Peripheral Stent showed durable results with zero fractures at 1 year.1,15-30

SUPERB Trial

At 1 year the Supera™ Stent demonstrated primary patency of 91% when nominally* deployed. At 3 years, freedom from targeted lesion revascularization (TLR) was 94% when nominally* deployed.1

91% patency at 1 year
PATENCY (K-M) AT 1 YEAR

When nominally deployed*

94% freedom from TLR at 3 years
FREEDOM FROM TLR AT 3 YEARS

When nominally deployed*

*Nominal deployment is defined as the stent length upon deployment being within +/- 10% of the labeled stent length. This data is from a non-powered post-hoc analysis. K-M=Kaplan Meier.

Unmatched Clinical Outcomes

Supera Stent has demonstrated unmatched clinical outcomes in comparison to other US pivotal trial results which primarily included simple lesions.*,1-12

1-Year Patency (KM)   3-Year Freedom from TLR
91% Supera™ Stent
Nominal1
  94% Supera™ Stent
Nominal1
87% Eluvia‡12   Not Reported Eluvia
84% Zilver PTX‡2   84% Zilver PTX‡2
83% Misago‡11   Not Available Misago
81% LifeStent‡3   76% LifeStent‡4
80% S.M.A.R.T.‡5   79% S.M.A.R.T.‡6
77% EverFlex‡7   70% EverFlex‡8
74% Innova‡9   Not Reported Innova
67% Pulsar‡10   Not Reported Pulsar

* Study reported 93.8% with Trans-Atlantic Inter-Society Consensus Document (TASC) A & B lesions and/or Rutherford class 2 or 3 lesions

NOTE: Results from clinical trials are not directly comparable. Information provided for educational purposes only.

Consistent Patency Regardless of Lesion Length

With some peripheral stents, increasing lesion lengths can lead to decreasing patency rates.31 The Supera™ Stent stands apart for its consistently high patency rates in lesions spanning lengths from 5.3 cm up to 28.0 cm*.

uniformly high patency rates from short to long lesions

*Published data was included if lesion length and patency were both available.

Note: Results from different clinical trials are not directly comparable. Information provided for educational purposes only.

Excellent Results from Simple to Complex Lesions

Whether treating simple (TASC A&B) or complex (TASC C&D) lesions, the Supera™ Stent is associated with impressive, consistent patency performance data at 1 year.13-15,32

Simple
Simple lesion Trial/Study MUNICH REGISTRY13 SUPERB32
Lesion Length 5.3cm 7.8cm
TASC A&B Lesions 100% 94%
1-Yr
Patency
86.7% 90.5%
Sites Single Center Multicenter (46 sites)
# Patients 70 264
Complex
Complex Lesion Trial/Study ST. LOUIS15 SUPERSUB14
Lesion Length 5.3cm 7.8cm
TASC C&D Lesions 78% 100%
CTOs Unknown 100%
1-Yr
Patency
85.6% 94.1%
Sites Single Center Single Center
# Patients 48 34

TASC: Trans-Atlantic Inter-Society Consensus

  • REFERENCES

    1. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
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    3. Laird J. et al., Circ Cardiovasc Interv. 2010;3:267-276.
    4. Laird J et al., J Endovasc Ther. 2012;19:1–9.
    5. S.M.A.R.T. Control IFU.
    6. Jaff, M., SMART Nitinol Self-Expanding Stent in the Treatment of Obstructive Superficial Femoral Artery Disease:  Three-year Clinical Outcomes from the STROLL Trial. ISET 2014.
    7. Matsumura J et al., J Vasc Surg 2013;58:73-83.
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    13. Treitl, K.M., et al. European Radiology.2017; 10.1007.
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    17. Montero-Baker M. et al., J Vasc Surg. 2016 Oct;64(4):1002-8.
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    31. Shroë H. Superficial femoral artery PTA or stenting? 5-Year results. CIRSE 2011; Munich, Germany
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