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EluviaTM DES Clinical Evidence

Eluvia Randomised Controlled Trials

Discover the evidence-backed solution for Superficial Femoral Artery (SFA) disease with Eluvia Drug-Eluting Stent.
Backed by three Randomised Controlled Trials, Boston Scientific confirms Eluvia's superiority, safety, and efficacy.
The results demonstrate that in any lesion, in any patient, and any trial, we show consistent results of ~90% primary patency at 1 year. 

SPORTS Randomised controlled trial.png​

SPORTS is Investigator-Sponsored, Core-lab Adjudicated, Randomised Controlled Trial Evaluating Drug-Eluting Stent or Primary Bare Nitinol Stent Application Versus Drug-Coated Balloons in Long SFA Lesions.​

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Clinical Studies  - EMINENT RCT

EMINENT is the largest Randomised Controlled Trial (2:1) comparing Eluvia™ Drug-Eluting Vascular Stent System to self-expanding bare metal stents (BMS) for SFA/PPA; EU multi-center; superiority trial; core lab adjudicated.​

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IMPERIAL Randomised controlled trial

IMPERIAL is the world’s first head-to-head DES SFA Trial, evaluating Boston Scientific Corporation’s Eluvia™ Drug-Eluting Vascular Stent System and Cook Medical’s Zilver™ PTX™ Stent.​

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References:

  1. SPORTS: Tepe G. SPORTS. TCT 2023, October 24, 2023, San Francisco, CA.​
  2. Eminent: Gouëffic Y, Torsello G, Zeller T, et al; EMINENT Investigators. 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(21):1564–1576.​
  3. Imperial: Müller-Hülsbeck S, Benko A, Soga Y, 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(3):368–375​

 

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.