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 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

Platform 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.

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

PLATFORM 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

17 studies show 0 fractures at 1 year with 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.
    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, 150 6F
2.06 mm
0.081 inches
5.5 mm 5.0 - 5.5 mm 20, 30, 40, 60, 80, 100, 120, 150, 180, 200
6.5 mm 6.0 - 6.5 mm 20, 30, 40, 60, 80, 100, 120, 150, 180, 200
7.5 mm 7.0 - 7.5 mm 20, 30, 40, 60, 80, 100

GUIDELINES FOR STENT SIZING

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™ STENT DEPLOYMENT

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
  •  

Supera™ Stent in calcified SFASupera™ Stent in calcified SFASupera™ Stent in calcified SFA Supera™ Stent in calcified SFA Supera™ Stent in calcified SFA

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, 80 cm
4.5 5.5 6.5 7.5
20 - - - -
30 - - - -
40 42045040-080 42055040-080 42065040-080 42075040-080
60 42045060-080 42055060-080 42065060-080 42075060-080
80 42045080-080 42055080-080 42065080-080 42075080-080
100 42045100-080 42055100-080 42065100-080 42075100-080
120 42045120-080 42055120-080 42065120-080 -
150 42045150-080 42055150-080 42065150-080 -
180 - 42055180-080 42065180-080 -
200 - 42055200-080 42065200-080 -

 

Length
(mm)
Stent Diameter (mm)
6F, 120 cm
4.5 5.5 6.5 7.5
20 42045020-120 42055020-120 42065020-120 42075020-120
30 42045030-120 42055030-120 42065030-120 42075030-120
40 42045040-120 42055040-120 42065040-120 42075040-120
60 42045060-120 42055060-120 42065060-120 42075060-120
80 42045080-120 42055080-120 42065080-120 42075080-120
100 42045100-120 42055100-120 42065100-120 42075100-120
120 42045120-120 42055120-120 42065120-120 -
150 42045150-120 42055150-120 42065150-120 -
180 - 42055180-120 42065180-120 -
200 - 42055200-120 42065200-120 -
  • 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.

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