RESULTS MATTER

The Supera™ Stent is known for the excellence of its clinical outcomes during percutaneous transluminal angioplasty (PTA) procedures, since this peripheral stent has been studied in more than 2,000 patients and 17 studies worldwide.

Demonstrates excellent clinical outcomes

Supera™ Stent demonstrated excellent 1 yr patency and 3 yr freedom from TLR in the SUPERB trial

UNMATCHED CLINICAL OUTCOMES

Demonstrated unmatched clinical outcomes in simple lesions across US pivotal stent trials

CONSISTENT ACROSS LESION LENGTH

Exhibits consistent 1-year primary patency results regardless of lesion length

STRONG OUTCOMES IN CALCIFICATION

Reveals strong clinical outcomes in severely calcified lesions at year 3 years

DESIGN MATTERS

Unlike any other stent design platform, the Supera™ Stent is uniquely designed to keep vessels open with its distinct platform, created by interwoven individual, flexible nitinol wires

High Compression Resistance

4x greater strength for compression resistance—so it can maintain a round, open lumen, which can be especially beneficial in calcified lesions

Low Chronic Outward Force

With 1:1 stent to vessel sizing, low chronic outward force results in minimal vessel injury

High Flexibility27 and Fracture Resistance

Unparalleled flexibility,27 which mimics the natural structure and movement of the anatomy

Zero stent fractures reported at 1 year in over 2,000 patients across 17 studies

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.

 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