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. These data are from a non-powered post-hoc analysis. KM = 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 with a majority as Trans-Atlantic Inter-Society Consensus Document (TASC) A&B lesion and/or majority as Rutherford Class 2 and 3.

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 Patency in Both Simple and 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.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

TASC: Trans-Atlantic Inter-Society Consensus

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.
    2. Dake M. et al., Circulation. 2016;133:1472-1483.
    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.
    8. Rocha-Singh, K., 3-Year Results of the DURABILITY II Study. VIVA 2013.
    9. US Innova IFU.
    10. US Pulsar IFU.
    11. Ohki T. et al. J Vasc Surg. 2016 Feb;63(2):370-6.
    12. Gray W. et al., Lancet 2018;392:1541-51.
    13. Treitl, K.M., et al. European Radiology.2017; 10.1007.
    14. Palena L.M. et al. Catheterization and Cardiovascular Intervention.2016.
    15. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
    16. George JC. et al., J Vasc Interv Radiol. 2014 Jun;25(6):954-61.
    17. Montero-Baker M. et al., J Vasc Surg. 2016 Oct;64(4):1002-8.
    18. Scheinert D. et al., J Endovasc Ther. 2011 Dec;18(6):745-52.
    19. Werner M. et al., EuroIntervention. 2014 Nov;10(7):861-8.
    20. San Norberto EM. et al., Ann Vasc Surg. 2017 May;41:186-195.
    21. Chan YC. et al., J Vasc Surg. 2015 Nov;62(5):1201-9.
    22. Dumantepe M. Vasc Endovascular Surg. 2017 Jul;51(5):240-246.
    23. Goltz JP. et al., J Endovasc Ther. 2012 Jun;19(3):450-6.
    24. León LR Jr. et al., J Vasc Surg. 2013 Apr;57(4):1014-22.
    25. Myint M. et al., J Endovasc Ther. 2016 Jun;23(3):433-41.
    26. Palena LM. et al., J Endovasc Ther. 2018 Oct;25(5):588-591.
    27. Scheinert D. et al., JACC Cardiovasc Interv. 2013 Jan;6(1):65-71.
    28. Steiner S. et al., J Endovasc Ther. 2016 Apr;23(2):347-55.
    29. Teymen B. et al., Vascular. 2018 Feb;26(1):54-61.
    30. Bhatt H. et al., Cardiovasc Revasc Med. 2018 Jul;19(5 Pt A):512-515.
    31. Shroë H. Superficial femoral artery PTA or stenting? 5-Year results. CIRSE 2011; Munich, Germany
    32. Garcia L. et al. Circ Cardiovasc Interv. 2015; 8:e00937.
Important Safety Information

MAT-2008210 v1.0

IMPORTANT SAFETY INFORMATION

Rx  Supera™ Peripheral Stent System

 

Indications:
The Supera™ Peripheral Stent System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters of 4.0 to 6.5 mm, and lesion lengths up to 140 mm.

Contraindications:

The Supera™ Peripheral Stent System is contraindicated in:

  • patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or stent delivery system
  • patients who cannot receive antiplatelet or anticoagulation therapy. Based on in vivo thrombogenicity testing, the device should not be used in patients who cannot be anticoagulated as there may be some thrombus formation in the absence of anticoagulation.


Warnings:

  • This device is intended for single-use only. Do not reuse. Do not resterilize. Do not use if the package is opened or damaged.
  • Use this device prior to the “Use By” date as specified on the device package label. Store in a dry, dark, cool place.
  • DO NOT use if it is suspected that the sterility of the device has been compromised.
  • Persons with known hypersensitivities to Nitinol and / or its components (e.g. nickel titanium) may suffer an allergic reaction to this implant.
  • Administer appropriate antiplatelet therapy pre- and post-procedure.
  • Careful attention should be paid when sizing and deploying the stent to prevent stent elongation. In the SUPERB clinical study, stent elongation was associated with a decrease in patency at 12 months.


Precautions: The Supera™ Peripheral Stent System should only be used by physicians and medical personnel trained in vascular interventional techniques and trained on the use of this device.

  • The long-term safety and effectiveness of the Supera™ Peripheral Stent System has not been established beyond three years.
  • The safety and effectiveness of the Supera™ Peripheral Stent System has not been established in patients who:
    • are less than 18 years old
    • are pregnant or lactating
    • have in-stent restenosis of the target lesion
    • have known hypersensitivity to any component of the stent system (e.g., nickel)
    • cannot tolerate contrast media and cannot be pre-treated
    • have uncontrolled hypercoaguability and / or other coagulopathy
  • This device is not designed for use with contrast media injection systems or power injection systems.
  • The flexible design of the Supera™ Stent may result in variation in the deployed stent length.

 

Magnetic Resonance Imaging (MRI)

A patient with this device can be scanned safely only under specific conditions. Failure to follow the conditions may result in severe injury.

Non-clinical testing has demonstrated the Supera™ Stents are MR Conditional for lengths up to 250 mm. A patient with this stent can be scanned safely, immediately after placement, under the following conditions:

  • Static magnetic field of 1.5 or 3.0 Tesla
  • Highest spatial gradient magnetic field of 2,500 Gauss/cm or less
  • Maximum MR whole-body-averaged specific absorption rate (SAR) of
    • 2 W/kg for landmarks (i.e. center of RF coil) above the umbilicus
    • 1 W/kg for landmarks below the umbilicus and above the mid-thigh
    • 0.5 W/kg for landmarks below the mid-thigh for 15 minutes of scanning (per pulse sequence), operating in the Normal Operating Mode (i.e., MR system mode of operation where there is no physiological stress to the patient). The legs of the patient should not be touching during the procedure.


Potential Adverse Events: Potential adverse events include, but are not limited to:

  • Abrupt closure
  • Allergic reaction (contrast medium; drug; stent material)
  • Amputation or limb loss
  • Aneurysm or pseudoaneurysm in vessel or at vascular access site
  • Angina or coronary ischemia
  • Arrhythmia (including premature beats, bradycardia, atrial or ventricular tachycardia, atrial or ventricular fibrillation)
  • Arteriovenous fistula
  • Bleeding complications requiring transfusion or surgical intervention
  • Death
  • Detachment of a system component or implantation in an unintended site
  • Embolization, arterial or other (e.g. air, tissue, plaque, thrombotic material, or stent)
  • Emergent surgery
  • Fever
  • Hematoma or hemorrhagic event, with or without surgical repair
  • Hyperperfusion syndrome
  • Hypertension / Hypotension
  • Infection
  • Myocardial infarction
  • Pain (leg, foot, and/or insertion site)
  • Partial stent deployment
  • Peripheral nerve injury
  • Pulmonary embolism
  • Renal failure or insufficiency
  • Restenosis of vessel in stented segment
  • Shock
  • Stent malapposition or migration, which may require emergency surgery to remove stent
  • Stent strut fracture
  • Thrombosis or occlusion
  • Stroke
  • Transient ischemic attack
  • Venous thromboembolism
  • Vessel dissection, perforation or rupture
  • Vessel spasm or recoil
  • Worsening claudication or rest pain

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

MAT-2103597 v1.0

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