CARDIOVASCULAR
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HOW TO DEPLOY GUIDE
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The Supera™ Peripheral Stent is indicated for the superficial femoral artery (SFA) and the proximal popliteal artery. Engineered by a unique interwoven wire technology, this nitinol stent offers physicians unmatched clinical outcomes5-16 across varied lesion complexities and lengths.1-4

 

To learn more about Supera™ Stent, simply request a free demonstration and your local Abbott representative will be in touch shortly.

 

Request a Demo

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.3,5-16

Demonstrates excellent clinical outcomes

Supera™ Stent demonstrated excellent 1 yr patency and 3 yr freedom from TLR in the SUPERB trial.5

1

Unmatched clinical outcomes

Demonstrated unmatched clinical outcomes in simple lesions across US pivotal stent trials5-20

2

Consistent across lesion length

Exhibits consistent 1-year primary patency results regardless of lesion length17-25

3

Strong outcomes in calcification

Reveals strong clinical outcomes in severely calcified lesions at year 3 years5

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

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
High Compression Resistance26

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
Low Chronic Outward Force26

One sizing, which exerts the least chronic outward force and results in minimal vessel injury28

High Flexibility and Fracture Resistance
High Flexibility27 and Fracture Resistance5

Unparalleled flexibility,27 which mimics the natural structure and movement of the anatomy29-31

Zero stent fractures reported at 1 year in over 2,000 patients across 17 studies3,5-20

  • References

    1. Treitl, K.M., et al. European Radiology.2017; 10.1007.
    2. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267                                                                  
    3. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
    4. Palena L.M. et al. Catheterization and Cardiovascular Intervention.2016.
    5. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
    6. Gray W. et al.,  Lancet 2018;392:1541-51.
    7. Dake M. et al., Circulation. 2016;133:1472-1483.
    8. Laird J. et al., Circ Cardiovasc Interv. 2010;3:267-276.
    9. Laird J et al., J Endovasc Ther. 2012;19:1–9.
    10. S.M.A.R.T. Control IFU.
    11. 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.
    12. Matsumura J et al., J Vasc Surg 2013;58:73-83.
    13. Rocha-Singh, K., 3-Year Results of the DURABILITY II Study. VIVA 2013.
    14. US Innova IFU.
    15. US Pulsar IFU.
    16. Ohki T. et al. J Vasc Surg. 2016 Feb;63(2):370-6.
    17. Treitl, K.M., et al. European Radiology. 2017; 10.1007
    18. Garcia L. et al. Circ Cardiovasc Interv. 2015;8:e000937
    19. Scheinert D. et al., J Endovasc Ther. 2011 Dec;18(6):745-52.
    20. San Norberto EM. et al., Ann Vasc Surg. 2017 May;41:186-195.
    21. Werner M. et al., EuroIntervention. 2014 Nov;10(7):861-8.
    22. George JC. et al., J Vasc Interv Radiol. 2014 Jun;25(6):954-61.
    23. Montero-Baker M. et al., J Vasc Surg. 2016 Oct;64(4):1002-8.
    24. Brescia A. et al. J Vasc Surg. 2015 Mar 6. pii: S0741-5214(15)00132-9
    25. Palena L.M. et al. Catheterization and Cardiovascular Interventions 2016
    26. Competitors tested include Astron Pulsar-18, Complete SE, EverFlex, Innova, LifeStent, Misago, S.M.A.R.T., and Zilver PTX. Test(s) performed by and data on file at Abbott.
    27. Flexibility is defined as kink resistance.  Competitors tested include Astron Pulsar-18, Complete SE,  EverFlex, Innova, LifeStent, Misago, S.M.A.R.T., and Zilver PTX. Test(s) performed by and data on file at Abbott
    28. Zhao HQ et al. Cardiovasc Intervent Radiol. 2009;32(4):720-6
    29. Arena F. et al., J Vasc Med Surg. 2013:1;116.
    30. Chen Y. et al., J Vasc Surg 2014;59:384-91.
    31. Test(s) performed by and data on file at Abbott

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.3,5-20

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.5

Patency (K-M) at 1 year
When nominally deployed*

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-Year Patency (KM)   3-Year Freedom from TLR
91% Supera™ Stent
Nominal
  94% Supera™ Stent
Nominal
87% Eluvia‡17   Not Reported Eluvia
84% Zilver PTX‡18   84% Zilver PTX‡18
83% Misago‡19   Not Available Misago
81% LifeStent‡20   76% LifeStent‡21
80% S.M.A.R.T.‡22   79% S.M.A.R.T.‡23
77% EverFlex‡24   70% EverFlex‡25
74% Innova‡26   Not Reported Innova
67% Pulsar‡27   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 EVEN IN LONG LESIONS

With some peripheral stents, increasing lesion lengths can lead to decreasing patency rates.28 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. **Multiple stents used for longer lengths.

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.1-4

 

Simple
Simple lesion Trial/Study MUNICH REGISTRY1 SUPERB2
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. LOUIS3 SUPERBSUB4
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. Treitl, K.M., et al. European Radiology.2017; 10.1007.
    2. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267
    3. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
    4. Palena L.M. et al. Catheterization and Cardiovascular Intervention.2016.
    5. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
    6. Gray W. et al.,  Lancet 2018;392:1541-51.
    7. Dake M. et al., Circulation. 2016;133:1472-1483.
    8. Laird J. et al., Circ Cardiovasc Interv. 2010;3:267-276.
    9. Laird J et al., J Endovasc Ther. 2012;19:1–9.
    10. S.M.A.R.T. Control IFU.
    11. 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.
    12. Matsumura J et al., J Vasc Surg 2013;58:73-83.
    13. Rocha-Singh, K., 3-Year Results of the DURABILITY II Study. VIVA 2013.
    14. US Innova IFU.
    15. US Pulsar IFU.
    16. Ohki T. et al. J Vasc Surg. 2016 Feb;63(2):370-6.
    17. Gray WA, et al. A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet. 2018;392:1541-1551. doi: https://doi.org/10.1016/S0140-6736(18)32262-1.
    18. Dake MD, et al. Durable clinical effectiveness with paclitaxel-eluting stents in the femoropopliteal artery: 5-year results of the Zilver PTX randomized trial. Circulation. 2016;133:1472-1483. doi: 10.1161/CIRCULATIONAHA.115.016900.
    19. Ohki T, et al. OSPREY investigators. One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease. J Vasc Surg. 2016;63:370-376.
    20. Laird JR, et al. Nitinol stent implantation versus balloon angioplasty for lesions in the superficial femoral artery and proximal popliteal artery: twelve-month results from the RESILIENT randomized trial. Circ Cardiovasc Interv. 2010;3:267-276. doi: 10.1161/CIRCINTERVENTIONS.109.903468.
    21. 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 from the RESILIENT randomized trial. J Endovasc Ther. 2012;19:1-9. doi: 10.1583/11-3627.1.
    22. S.M.A.R.T. Control IFU.
    23. Jaff MR. S.M.A.R.T. nitinol self-expanding stent in the treatment of obstructive superficial femoral artery disease: three-year clinical outcomes from the STROLL trial. ISET 2014.
    24. Matsumura JS, et al. The United States stuDy for evalUating endovasculaR treAtments of lesions in the superficial femoral artery and proximal popliteal By usIng the Protégé EverfLex NitInol sTent sYstem II (DURABILITY II). J Vasc Surg. 2013;58:73-83. doi: 10.1016/j.jvs.2012.12.066.
    25. Rocha-Singh KJ, et al. 3-year results of the DURABILITY II study. VIVA 2013.
    26. US Innova IFU.
    27. US Pulsar IFU.
    28. Shroë H. Superficial femoral artery PTA or stenting? 5-Year results. CIRSE 2011; Munich, Germany

DESIGN MATTERS—UNIQUE INTERWOVEN DESIGN OF SUPERA™ STENT

Breakthrough Technology in Stent Platform

The Supera™ Stent’s unique design results in a platform with features unmatched among standard nitinol peripheral stents:

High Compression Resistance
Strength—its high resistance to compression17
Low Chronic Outward Force
Low chronic outward force against vessel walls18
High Flexibility and Fracture Resistance
High flexibility,19 which allows for fracture resistance2
View the Supera™ Stent Difference

The interwoven nitinol design provides high structural integrity and kink resistance, producing the features that set the Supera™ Stent apart.

Video showing Supera™ Stent flexibility
Offering Unparalleled Strength for Compression Resistance

The Supera™ Stent exhibits more than 4 times the compression resistance of all other self-expanding nitinol stents, which are laser cut from an inflexible nitinol tube.18 Benchtop testing with the 5 pounds of force results in compression of a standard laser-cut nitinol stent (below left). When the same force is applied to the Supera™ Stent, it retains its circular form (below right).

In the clinical setting, those results are illustrated—by being deployed in the same patient and same vessel—via the angiogram and intravacular ultrasound (IVUS) images below. In the IVUS images, note the compression of the standard nitinol stent, while the Supera™ Stent was able to retain its circular shape. Such performance is particularly important in heavily calcified lesions.


Supera™ Stent offers unparalleled compression resistance

Source: Angiogram and IVUS images courtesy of Dr. Andrej Schmidt.

Exerting the Least Chronic Outward Force on the Vessel Wall17

While laser-cut nitinol stents are designed and required to be oversized for deployment, the Supera™ Stent is unique in that it is sized 1:1 with the vessel diameter. So as seen in the image below, the laser-cut stents inherently exert force on the vessel wall throughout the lifetime of the stent, which in turn can result in endovascular injury over the long term. The lower chronic outward force (COF) with the Supera™ Stent results in fewer vessel injuries.17,20

STANDARD NITINOL STENT (SNS) DESIGNS

Pushes against the vessel to open, through lifetime of SNS

STENT OVERSIZING   HIGH COF1 VESSEL INJURY2
Chronic outward force (COF) is exerted on vessel by self-expanding stents due to inherent oversizing
SUPERA™ STENT

1:1 sizing allows to scaffold the vessel to maintain open

SIZING 1:1   LOW COF1

MINIMAL VESSEL
INJURY2

Supera™ is sized 1:1 with the prepared vessel and therefore has minimal chronic outward force
Providing Unparalled Flexibility19 and Zero Fractures2

All other self-expanding nitinol stents are fashioned from a rigid, inflexible nitinol tube. As shown in the photo below, such laser-cut stents are less likely to conform to a dynamic vascular environment and can potentially kink and fracture in tortuous vessels (left).

L-R: other nitinol stents can kink; Supera™ Stent has great flexibilityL-R: other nitinol stents can kink; Supera™ Stent has great flexibility

With the Supera™ Stent, however, individual flexible nitinol wires are interwoven for unparalleled flexibility,20 excellent kink resistance, and the ability to mimic the natural movement of the anatomy21-23 (right). Given the twisting and compression characteristics of the superficial femoral artery and proximal popliteal, this stent is an effective choice.

Consequently, data on over 2,000 patients published in 17 studies have shown that at 1 year the Supera™ Stent has zero fractures.2,3,24-38

  • References

    1. Treitl, K.M., et al. European Radiology.2017; 10.1007.
    2. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267
    3. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
    4. Palena L.M. et al. Catheterization and Cardiovascular Intervention.2016.
    5. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
    6. Gray W. et al.,  Lancet 2018;392:1541-51.
    7. Dake M. et al., Circulation. 2016;133:1472-1483.
    8. Laird J. et al., Circ Cardiovasc Interv. 2010;3:267-276.
    9. Laird J et al., J Endovasc Ther. 2012;19:1–9.
    10. S.M.A.R.T. Control IFU.
    11. 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.
    12. Matsumura J et al., J Vasc Surg 2013;58:73-83.
    13. Rocha-Singh, K., 3-Year Results of the DURABILITY II Study. VIVA 2013.
    14. US Innova IFU.
    15. US Pulsar IFU.
    16. Ohki T. et al. J Vasc Surg. 2016 Feb;63(2):370-6.
    17. Test(s) performed by and data on file at Abbott.
    18. Competitors tested include Astron Pulsar-18, Complete SE, EverFlex, Innova, LifeStent, Misago, S.M.A.R.T., and Zilver PTX. Test(s) performed by and data on file at Abbott.
    19. Flexibility is defined as kink resistance.  Competitors tested include Astron Pulsar-18, Complete SE,  EverFlex, Innova, LifeStent, Misago, S.M.A.R.T., and Zilver PTX. Test(s) performed by and data on file at Abbott.
    20. Zhao HQ et al. Cardiovasc Intervent Radiol. 2009;32(4):720-6.
    21. Arena F. et al., J Vasc Med Surg. 2013:1;116.
    22. Chen Y. et al., J Vasc Surg 2014;59:384-91.
    23. Test(s) performed by and data on file at Abbott
    24. Chan YC. et al., J Vasc Surg. 2015 Nov;62(5):1201-9.
    25. Dumantepe M. Vasc Endovascular Surg. 2017 Jul;51(5):240-246.
    26. George JC. et al., J Vasc Interv Radiol. 2014 Jun;25(6):954-61.
    27. Goltz JP. et al., J Endovasc Ther. 2012 Jun;19(3):450-6.
    28. León LR Jr. et al., J Vasc Surg. 2013 Apr;57(4):1014-22.
    29. Montero-Baker M. et al., J Vasc Surg. 2016 Oct;64(4):1002-8.
    30. Myint M. et al., J Endovasc Ther. 2016 Jun;23(3):433-41.
    31. Palena LM. et al., J Endovasc Ther. 2018 Oct;25(5):588-591.
    32. Scheinert D. et al., JACC Cardiovasc Interv. 2013 Jan;6(1):65-71.
    33. Scheinert D. et al., J Endovasc Ther. 2011 Dec;18(6):745-52.
    34. Steiner S. et al., J Endovasc Ther. 2016 Apr;23(2):347-55.
    35. Werner M. et al., EuroIntervention. 2014 Nov;10(7):861-8.
    36. San Norberto EM. et al., Ann Vasc Surg. 2017 May;41:186-195.
    37. Teymen B. et al., Vascular. 2018 Feb;26(1):54-61.
    38. Bhatt H. et al., Cardiovasc Revasc Med. 2018 Jul;19(5 Pt A):512-515.

SUPERA™ STENT LESION PREPARATION

Per the 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 to the IFU for additional information.

 

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

GUIDELINES FOR STENT SIZING

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 with Supera™ Stent

The image below is a percutaneous transluminal angioplasty (PTA) balloon inflation example for a 5.5 mm Supera™ 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.

SUPERA RESOURCES

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

  • References

    1. Treitl, K.M., et al. European Radiology.2017; 10.1007.
    2. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267
    3. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
    4. Palena L.M. et al. Catheterization and Cardiovascular Intervention.2016.
    5. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
    6. Gray W. et al.,  Lancet 2018;392:1541-51.
    7. Dake M. et al., Circulation. 2016;133:1472-1483.
    8. Laird J. et al., Circ Cardiovasc Interv. 2010;3:267-276.
    9. Laird J et al., J Endovasc Ther. 2012;19:1–9.
    10. S.M.A.R.T. Control IFU.
    11. 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.
    12. Matsumura J et al., J Vasc Surg 2013;58:73-83.
    13. Rocha-Singh, K., 3-Year Results of the DURABILITY II Study. VIVA 2013.
    14. US Innova IFU.
    15. US Pulsar IFU.
    16. Ohki T. et al. J Vasc Surg. 2016 Feb;63(2):370-6.

SUPERA™ STENT CASE STUDIES

Case Study 1: Long, Calcified Superficial Femoral Artery (SFA)

Case background:

  • 67-year-old male with left lower extremity claudication
  • Ankle brachial index (ABI) of 0.75 on the left
  •  

Source: Case and images courtesy of Dr. Ehrin Armstrong.

Case Study 2: Long, Calcified, Occluded SFA

Case background:

  • 72-year-old male with a history of diabetes, hypertension, dyslipidemia, and previous myocardial infarction treated by percutaneous coronary intervention (PCI)
  • Bilateral Rutherford stage 3 claudication
  • Left SFA occlusion with moderate-to-severe calcification
  • Previous treatment in the right SFA: heavily calcified subtotal occlusion required orbital atherectomy, percutaneous transluminal angioplasty (PTA), and two overlapping standard nitinol stents
  •  

1.

Successful Supera™ Stent implant in long, calcified, occluded SFA

2.

successful Supera™ Stent implant in long, calcified, occluded SFAsuccessful Supera™ Stent implant in long, calcified, occluded SFA

3.

Successful Supera™ Stent implant in long, calcified, occluded SFA

4.

Successful Supera™ Stent implant in long, calcified, occluded SFA

Source: Case and images courtesy of Dr. Sahil Parikh.

  • References

    1. Treitl, K.M., et al. European Radiology.2017; 10.1007.
    2. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267
    3. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
    4. Palena L.M. et al. Catheterization and Cardiovascular Intervention.2016.
    5. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
    6. Gray W. et al.,  Lancet 2018;392:1541-51.
    7. Dake M. et al., Circulation. 2016;133:1472-1483.
    8. Laird J. et al., Circ Cardiovasc Interv. 2010;3:267-276.
    9. Laird J et al., J Endovasc Ther. 2012;19:1–9.
    10. S.M.A.R.T. Control IFU.
    11. 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.
    12. Matsumura J et al., J Vasc Surg 2013;58:73-83.
    13. Rocha-Singh, K., 3-Year Results of the DURABILITY II Study. VIVA 2013.
    14. US Innova IFU.
    15. US Pulsar IFU.
    16. Ohki T. et al. J Vasc Surg. 2016 Feb;63(2):370-6.

ORDERING INFORMATION

 

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

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

  • References

     

    1. Treitl, K.M., et al. European Radiology.2017; 10.1007.
    2. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267
    3. Brescia AA. et al., J Vasc Surg. 2015 Jun;61(6):1472-8
    4. Palena L.M. et al. Catheterization and Cardiovascular Intervention.2016.
    5. Garcia L. et al., Catheterization and Cardiovascular Interventions 2017 Jun 1;89(7):1259-1267.
    6. Gray W. et al.,  Lancet 2018;392:1541-51.
    7. Dake M. et al., Circulation. 2016;133:1472-1483.
    8. Laird J. et al., Circ Cardiovasc Interv. 2010;3:267-276.
    9. Laird J et al., J Endovasc Ther. 2012;19:1–9.
    10. S.M.A.R.T. Control IFU.
    11. 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.
    12. Matsumura J et al., J Vasc Surg 2013;58:73-83.
    13. Rocha-Singh, K., 3-Year Results of the DURABILITY II Study. VIVA 2013.
    14. US Innova IFU.
    15. US Pulsar IFU.
    16. Ohki T. et al. J Vasc Surg. 2016 Feb;63(2):370-6.

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
  • 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.

AP2947962-WBU Rev. A

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