CARDIOVASCULAR
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The Supera peripheral stent occupies a unique class of stent technology. With the Supera stent’s ability to mimic the anatomy's natural movement while optimizing luminal gain, healthcare professionals find this vascular stent effective when treating the dynamic environment of the superficial femoral artery (SFA) and proximal popliteal arteries.

 

THE CLINICALLY PROVEN1 SUPERA STENT

When peripheral artery disease causes blockages in the SFA and popliteal arteries, the Supera stent can restore blood flow during a percutaneous transluminal angioplasty (PTA) procedure. Supera has been analyzed in over 1,600 patients worldwide.2

Innovative, Interwoven Nitinol Design

  • Allows Supera to mimic the natural movement of the anatomy
  • Supports the vessel with minimal chronic outward force3,4

Strength and Flexibility

  • Provides unparalleled strength and flexibility, with more than four times the compression resistance of all other standard Nitinol stents5,6
  • Has visible compression resistance in severely calcified lesions, maintaining a round, open lumen7

Clinical Efficacy

  • 87.6% freedom from target lesion revascularization (TLR) in severely calcified lesions at 3 years (n = 325)8
  • 86.3% primary patency (K-M) at 1 year3
  • 0 fracture at 1 year; 1 fracture at 3 years8

 

 

References

1. Garcia L., et al., Wire-interwoven Nitinol stent outcome in the superficial femoral and proximal popliteal arteries: Twelve-month results of the SUPERB Trial. Circ Cardiovasc Interv. 2015;8: pii: e000937. doi: 10.1161/CIRCINTERVENTIONS.113.000937.
2. 1,636 patients studied, see Werner M, 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 P, 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 JP, 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 YC, et al. Primary stenting of femoropopliteal atherosclerotic lesions using new helical interwoven nitinol stents. J Vasc Surg. 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 JC, et al. SUPERA interwoven nitinol stent outcomes in above-knee interventions (SAKE) study. J Vasc Interv Radiol. 2014;25: 954-961. 80 patients • Dumantepe M, et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm results. Vascular. 2015;Feb 16. pii: 1708538114568884. 36 patients • Varcoe R. A Real World Experience Using SUPERA in Long, Challenging Lesions. LINC 2015. 105 patients • Brescia AA, et al. Stenting of femoropopliteal lesions using interwoven nitinol stents. J Vasc Surg. 2015; 61:1472-1478. 38 patients • Mussa F. 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 LM, et al. SUPERSUB Trial: 1-Year Outcomes of Supera Subinitimal Stenting in CLI Patients. 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;8:e000937. 264 patients.
3. Supera Peripheral Stent System Instructions for Use.
4. Measurements taken at upper limit of labeled vessel diameter mm. Data on file at Abbott.
5. 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.
6. 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.
7. Characteristically round lumens supported by: Arena FJ, Arena FA. Intravascular ultrasound evaluation of interwoven Nitinol stents at implant. J Vasc Med Surg. 2013:1;116. doi: 10.4172/2329-6925.1000116.
8. Garcia LA, et al. SUPERB Final 3-Year Outcomes Using Interwoven Nitinol Biometric Supera Stent. Catheterization and Cardiovascular Interventions 2017.

CLINICAL DATA FOR THE SUPERA STENT

Clinically Proven and Widely Studied

The Supera stent has been studied with over 1,600 patients worldwide in the SUPERB trial and 13 retrospective studies.

Notably, in all of the 14 studies, the Supera vascular stent showed durable results with zero fractures at 1 year.1 Supera demonstrated primary patency of 86.3% at 1 year (K-M) and 90.5% when nominally deployed.2,3 At 3 years, freedom from targeted lesion revascularization (TLR) was 83%, and 94% when nominally deployed.2 Overall, Supera stent is clinically proven with excellent long-term outcomes.

excellent TLR and patency data

Freedom from Target Lesion Revascularization

Compared to standard Nitinol stents, Supera showed excellent outcomes, particularly when deployed at nominal stent length.

Supera data superior to other Nitinol stents

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

More Supera Stent Data

Review more research findings on the Supera stent.

 

 

References

1. 1,636 patients studied, see Werner M, 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 P, 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 JP, 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 YC, et al. Primary stenting of femoropopliteal atherosclerotic lesions using new helical interwoven nitinol stents. J Vasc Surg. 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 JC, et al. SUPERA interwoven nitinol stent outcomes in above-knee interventions (SAKE) study. J Vasc Interv Radiol. 2014;25: 954-961. 80 patients • Dumantepe M, et al. Treatment of complex atherosclerotic femoropopliteal artery disease with a self-expanding interwoven nitinol stent: Midterm results. Vascular. 2015;Feb 16. pii: 1708538114568884. 36 patients • Varcoe R. A Real World Experience Using SUPERA in Long, Challenging Lesions. LINC 2015. 105 patients • Brescia AA, et al. Stenting of femoropopliteal lesions using interwoven nitinol stents. J Vasc Surg. 2015; 61:1472-1478. 38 patients • Mussa F. 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 LM, et al. SUPERSUB Trial: 1-Year Outcomes of Supera Subinitimal Stenting in CLI Patients. 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;8:e000937. 264 patients.
2. Supera Peripheral Stent System Instructions for Use—nominal analysis was a non-powered post-hoc analysis.
3. 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;8:e000937. doi: 10.1161/CIRCINTERVENTIONS.113.000937.
4. STROLL 1-year data: Ansel G, LINC 2013; 2-year data: Gray W, ISET 2013; 3-year data: Jaff M, ISET 2014. 
5. Laird JR, et al. Nitinol stent implantation vs. balloon angioplasty for lesions in the superficial femoral and proximal popliteal arteries of patients with claudication: Three-year follow-up. J Endovasc Ther. 2012;19:1–9. doi: 10.1583/11-3627.1.
6. DURABILITY II: Rocha-Singh KJ, VIVA 2013; Razavi M, ISET 2014.

SUPERA STENT EFFICACY

Supera in Long Lesions

A sub-group analysis of the SUPERB trial results, at 1 year, showed similar freedom from restenosis rates when comparing short lesions (mean 35.4 mm) and long lesions (mean 126 mm).1

Lesions Free from Restenosis
12 Months, SUPERB Trial

88% freedom from restenosis at 1 and 3 years

Supera in Severely Calcified Lesions

Despite the challenge posed by severely calcified lesions (45% of patients in the SUPERB trial), the Supera stent demonstrated 89% primary patency (VIVA) at one year in this subgroup. Freedom from targeted lesion revascularization (TLR) for this same group was 95% at 1 year and 88% at 3 years.2

Freedom from TLR in Severely Calcified Lesions

Excellent freedom from restenosis at 1 and 3 years

Lesion Preparation

Per Instructions for Use, physicians should prepare the vessel using standard angioplasty technique; balloon size should be greater than or equal to the stent diameter. Refer also to the Lesion Treatment section in the IFU.

Labeled Stent
Diameter
Reference
Vessel Diameter
Nominal Stent Length
(mm)
Catheter Outer
Sheath Diameter
4.5 mm 4.0 - 4.5 mm 20, 30, 40, 60, 80, 100, 120 6F
2.06 mm
0.081 inches
5.0 mm 4.5 - 5.0 mm 20, 30, 40, 60, 80, 100, 120
5.5 mm 5.0 - 5.5 mm 20, 30, 40, 60, 80, 100, 120, 150
6.0 mm 5.5 - 6.0 mm 20, 30, 40, 60, 80, 100, 120, 150
6.5 mm 6.0 - 6.5 mm 20, 30, 40, 60, 80, 100, 120, 150
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SUPERA STENT SIZING CHART


The illustration below shows that every 0.5-mm increase provides an estimated 19% to 27% growth in luminal gain (cross-sectional area).

percent increase in luminal gain

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

percent increase in luminal gain

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.

 

 

References

1. Supera U.S. IFU.
2. Garcia L, et al. The SUPERB Trial: 3-Year Results. VIVA 2014.

SUPERA RESOURCES

The stent deployment guidestent deployment guide offers general information as well as step-by-step guidelines for deploying the Supera stent.

ORDERING INFORMATION

Our online product catalogs provide the very latest information available, right at your fingertips. Download catalogs by product family in PDF format, or view the entire Abbott Vascular inventory in Excel. Product barcodes enable direct scanning for easy reordering.

Length
(mm)
Stent Diameter (mm)
6F, 120 mm
4.5 5.0 5.5 6.0 6.5
20 S-45-020-120-P6 S-50-020-120-P6 S-55-020-120-P6 S-60-020-120-P6 S-65-020-120-P6
30 S-45-030-120-P6 S-50-030-120-P6 S-55-030-120-P6 S-60-030-120-P6 S-65-030-120-P6
40 S-45-040-120-P6 S-50-040-120-P6 S-55-040-120-P6 S-60-040-120-P6 S-65-040-120-P6
60 S-45-060-120-P6 S-50-060-120-P6 S-55-060-120-P6 S-60-060-120-P6 S-65-060-120-P6
80 S-45-080-120-P6 S-50-080-120-P6 S-55-080-120-P6 S-60-080-120-P6 S-65-080-120-P6
100 S-45-100-120-P6 S-50-100-120-P6 S-55-100-120-P6 S-60-100-120-P6 S-65-100-120-P6
120 S-45-120-120-P6 S-50-120-120-P6 S-55-120-120-P6 S-60-120-120-P6 S-65-120-120-P6
150     S-55-150-120-P6 S-60-150-120-P6 S-65-150-120-P6
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SUPERA ORDERING INFO

PRODUCT INFO

Our online product catalogs provide the very latest information available, right at your fingertips. Download catalogs by product family in PDF format, or view the entire Abbott Vascular inventory in Excel. Product barcodes enable direct scanning for easy reordering.

SUPERA DEPLOYMENT GUIDE

Our stent deployment guide offers insights and step-by-step guidelines for healthcare professionals deploying the Supera stent.

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.

AP2946400-WBU Rev. A

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