Supera Peripheral Stent System
VASCULAR
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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, Supera stent demonstrated 86.3% primary patency (K-M) at one year and 90.5% primary patency when nominally deployed2. The three year freedom from targeted lesion revascularization (TLR) was 83% and 94% when nominally deployed2. Overall, Supera stent is clinically proven with excellent long-term outcomes.

Supera Stent US 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. Supera Peripheral Stent System Instructions for Use - nominal analysis was a non-powered post-hoc analysis

SUPERA STENT - SUPERB TRIAL

SUPERB STUDY OVERVIEW

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 SAFETY 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

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).

Supera Superb Trial Lesion Characteristics

1. Rocha-Singh K., Performance Goals and Endpoint Assessments, Catheterization and Cardiovascular Interventions 69:910–919 (2007)

2. Supera Peripheral Stent System 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% of labeled stent length) is achieved, a higher primary patency of 90.5% was reported, compared to the overall 86.3% in the trial1.

1 Year Primary Patency (K-M)

Supera Stent Patency

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 nominally1. The data also showed a minimal change in freedom from TLR from one year to three years.

Freedom from TLR at 1,2, and 3 Years

Supera Stent Target Lesion Revascularization

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 Freedom from TLR 3 year data

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 System 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).1

Percent of lesions without restenosis by lesion length 

(12 months SUPERB TRIAL)

Supera Superb Trial Lesion Length

1. Supera Peripheral Stent System Instructions for Use

SUPERA STENT - SEVERE CALCIFICATION

Supera has Strong Outcomes in Severely Calcified Lesions

In the SUBERB 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

Calcium knee

Freedom from TLR% Over Time in Severe Calcium

Supera Freedom from TLR Over Time in Severe Calcium

Superb data

Supera Superb Data

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

SUPERA STENT - LESION PREPARATION

Per the Instructions for Use, prepare the vessel utilizing standard angioplasty technique using a balloon size greater than or equal to the stent diameter. (Refer to Lesion Treatment section in the IFU)

Supera Stent Full Range of Sizes

The illustration below shows that every 0.5 mm increase provides an estimated 19% to 27% growth in luminal gain as measured by the cross sectional area.

Supera Stent Luminal Gain

The image below is a PTA balloon inflation example for a 5.5mm stent:

Supera Stent Diameter

PRECAUTION: The post-dilated vessel should be at least the size of the stent diameter. If recommended vessel diameter cannot be gained, optimal stent deployment may not be achieved and revised stent sizing should be considered.

Supera Stent Orderning Information

PRODUCT INFO

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INDICATIONS AND IMPORTANT SAFETY INFORMATION

RxSupera® 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
  • 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

Prior to use, please reference the Instructions for Use at www.abbottvascular.com/ifu for more information on indications, contraindications, warnings, precautions, and adverse events.

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