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Decline
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More evidence. More confidence. More successful outcomes.

The only drug eluting technologies backed by 5 RCTs, and studies that will exceed 10,000 patients1-6

Restenosis is a significant issue and is impacted by the choice of superficial femoral artery (SFA) treatment

Restenosis remains a challenge and is highly prevalent⁷

High restenosis with BMS/PTA

 

Meta-analysis of randomised controlled trials revealed that bare metal stents (BMSs) and percutaneous transluminal angioplasty (PTA) are still widely used, despite being associated with high restenosis rates.⁸

Since the first use of PTA nearly 60 years ago, SFA disease management remains inconsistent BMS and PTA still widely used even though meta-analysis of randomised controlled trials reveal that they are associated with high restenosis rates.9-10

New-generation endovascular approaches, however, such as drug coated devices, have helped to reduce restenosis rates.10-11

Paclitaxel devices are effective and safe

Paclitaxel drug-eluting technologies (DETs) help reduce restenosis, resulting in better outcomes for patients vs BMS or plain old balloon angioplasty (POBA)¹⁰⁻¹¹

The EMINENT RCT combined with network meta-analysis of RCTs conclude that DES and DCBs respectively, result in greater primary patency versus non-drug devices.10-11

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 27,620
patients

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   27
studies

Our paclitaxel DCB Ranger™and DES Eluvia™ demonstrate significantly superior primary patency versus non-DETs¹¹⁻¹²

Ranger and Eluvia Patency
Visit Eluvia product page
Visit Ranger product page

All-cause mortality rates for paclitaxel-coated vs uncoated products¹⁰⁻¹⁴

PTX-coated vs uncoated products mortality
Visit Eluvia product page
Visit Ranger product page

Boston Scientific has superior DET devices for any SFA lesion, in any patient

Treat SFA lesions with the only drug eluting technology backed by 5 RCTs and included in studies that will exceed 10,000 patients  in over 15 countries¹¹⁻¹⁵

Click below to read more about the relevant clinical trial:

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5 RCTs  (IMPERIAL, EMINENT, COMPARE, RANGER II and RANGER)

IMPERIAL
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>10,000 patients
 

EMINENT
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Global clinical 
footprint

COMPARE

Eluvia demonstrates consistent outcomes in complex lesions in both real world evidence and RCTs

  12 month
Capsicum 87.1%24
Imperial RCT 91%25

Drug-Eluting Technologies

Summary of Eluvia drug-eluting stent

Eluvia™ Drug-Eluting Vascular Stent System

Designed to ensure targeted and sustained release to match the restenotic process of the SFA. Eluvia demonstrated superior primary patency versus bare metal stents.¹⁵

Learn more about Eluvia DES
Summary of Ranger drug-coated balloon

Ranger™ Drug-Coated Balloon

Designed with the lowest tip entry profile of any SFA DCB for a smooth delivery with excellent trackability.17 Ranger demonstrated consistently high primary patency near 90% versus uncoated PTA.12-24

Learn more about Ranger DCB
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Receive downloads for clinical data sheets and additional resources for our Drug-Eluting Technologies.

Explore resources
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Stay up to date with the latest DET news and events in your area.

Register

References

  1. Sachar R et al. RANGER II SFA Investigators. 1-year results from the RANGER II SFA randomized trial of the Ranger drug-coated balloon. JACC Cardiovasc Interv. 2021;10:1123–1133.​
  2. Gouëffic Y, et al. Efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: Primary results of the EMINENT randomized trial. Circulation. 2022;146:1564–1576.​
  3. Steiner S, et al. 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment. JACC Cardiovasc Interv. 2018;11:934–941.
  4. Steiner S, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020;41:2541–2552.​
  5. Müller-Hülsbeck S, et al. Two-year efficacy and safety results from the IMPERIAL Randomized study of the Eluvia polymer-coated drug-eluting stent and the Zilver PTX polymer-free drug-coated stent. Cardiovasc Intervent Radiol. 2021;44:368–375.​
  6. Marianne Brodmann, CIRSE 2022 Symposium: DET in complexities co-morbidities, and underserved patient populations.​
  7. Cho S, et al. Directional atherectomy for treating in-stent restenosis of the superficial femoral artery. Vasc Specialist Int. 2020;36(3):136–143.
  8. Kasapis C, et al. Routine stent implantation vs. percutaneous transluminal angioplasty in femoropopliteal artery disease: a meta-analysis of randomized controlled trials. Eur Heart J. 2009;30(1):44–55. 
  9. Aboyans V, et al. 2017 ESC Guidelines on the Diagnosis and Treatment of Peripheral Arterial Diseases, in collaboration with the European Society for Vascular Surgery (ESVS). Eur Heart J. 2018;39:763–816.
  10. Ullah W, et al. Safety and efficacy of drug-coated balloon for peripheral artery revascularization-A systematic review and meta-analysis. Catheter Cardiovasc Interv. 2022;99(4):1319–1326.
  11. Gouëffic Y, et al. Efficacy of a drug-eluting stent versus bare metal stents for symptomatic femoropopliteal peripheral artery disease: Primary results of the EMINENT randomized trial. Circulation. 2022;146:1564–1576.
  12. Sachar R, et al. RANGER II SFA Investigators. 1-year results from the RANGER II SFA randomized trial of the Ranger drug-coated balloon. JACC Cardiovasc Interv. 2021;10:1123–1133.
  13. Steiner S, et al. 12-month results from the first-in-human randomized study of the ranger paclitaxel-coated balloon for femoropopliteal treatment. JACC Cardiovasc Interv. 2018;11:934–941.
  14. Steiner S, et al. COMPARE: prospective, randomized, non-inferiority trial of high- vs. low-dose paclitaxel drug-coated balloons for femoropopliteal interventions. Eur Heart J. 2020;41:2541–2552.
  15. Müller-Hülsbeck S, et al. Two-year efficacy and safety results from the IMPERIAL Randomized study of the Eluvia polymer-coated drug-eluting stent and the Zilver PTX polymer-free drug-coated stent. Cardiovasc Intervent Radiol. 2021;44:368–375.
  16. Katsanos K, et al. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc;7(24):e011245.
  17. Subgroup Analysis of VOYAGER PAD presented at TCT. October 2020.
  18. Dinh K, et al. Mortality rates after paclitaxel-coated device use in patients with occlusive femoropopliteal disease: an updated systematic review and meta-analysis of randomized controlled trials. J Endovasc Ther. 2021;28(5):755–777.
  19. Nordanstig J, et al. Mortality with paclitaxel-coated devices in peripheral artery disease. N Engl J Med. 2020;383(26):2538–2546.
  20. Secemsky EA, et al. Longitudinal assessment of safety of femoropopliteal endovascular treatment with paclitaxel-coated devices among medicare beneficiaries: the SAFE-PAD study. JAMA Intern Med. 2021;181(8):1071–1080.
  21. Stavroulakis K, et al. 2-year outcomes of the Eluvia drug-eluting stent for the treatment of complex femoropopliteal lesions. JACC Cardiovasc Interv. 2021;14:692–701.
  22. Holden A. Single centre long-term experience with the Boston Scientific Eluvia DES in femoro-popliteal artery occlusive disease. Presented at Leipzig Interventional Course (LINC), Leipzig, Germany, 28–31 January 2020.
  23. Kum S. DES for SFA/Pop 12-month results of the DESAFINADO registry. Presented at Leipzig Interventional Course (LINC), Leipzig, Germany, 28–31 January 2020. 
  24. Lida O, et al. 1-year outcomes of fluoropolymer-based drug-eluting stent in femoropopliteal practice: predictors of restenosis and aneurysmal degeneration. JACC Cardiovasc Interv. 2022;15:630–638.
  25. Gray WA, Lancet. 2018 Sep 24. pii: S0140-6736(18)32262-1

Caution:
The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings, and instructions for use can be found in the product labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.