Eluvia™ Drug-Eluting Vascular Stent System

Name: Eluvia™ Drug-Eluting Vascular Stent System - Boston Scientific
Brand: Boston Scientific

Eluvia DES is designed to meet the challenges of the SFA with outstanding flexibility and precise stent placement. Only Eluvia DES offers sustained drug release, with the world's most proven polymer, to match the restenotic process of SFA.

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Eluvia is the #1 most-implanted SFA stent.¹

Eluvia DES provides consistent, durable outcomes in challenging superficial femoral artery (SFA) disease and features a polymer design for controlled drug release.

How it works

Engineered for the challenges of the SFA, Eluvia DES is the only drug-eluting stent designed to efficiently deliver drug to the target lesion for over a year, when restenosis is most likely to occur in the SFA.

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Clinical history of restenosis in nitinol stents.

Sustained drug release to match the SFA restenotic process

Eluvia DES is the ONLY SFA drug-eluting stent with a polymer coating, enabling efficient drug delivery. Eluvia DES' polymer maintains a steady release of drug during the height of restenosis, protects the drug from dissolving in the blood and ensures highly controlled drug delivery to the target lesion.

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The lowest drug dose density of any PTX therapy

Compared to other paclitaxel technologies, Eluvia DES has the lowest drug dose density at 0.167 (ug/mm²), 18x less than the Zilver PTX drug-coated stent.

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Eluvia's clinical data pyramid and statistics.

Backed by unrivaled clinical evidence

Boston Scientific is committed to advancing science in the fight against PAD. The Eluvia clinical program is comprised of an impressive set of comparative effectiveness randomized controlled trials and global real-world registries that have studied long-term outcomes of complex SFA disease in over 2,250 patients. Across the three level-1, head-to-head comparative effectiveness trials, EMINENT RCT, IMPERIAL RCT and SPORTS RCT, Eluvia DES demonstrated consistent and statistically superior efficacy results at 1 year.

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References:

*These investigator-sponsored studies are supported by grant funding from Boston Scientific. Boston Scientific is not responsible for the collection, analysis or reporting of these studies, which remain the sole responsibility of the investigators. Information for the use in countries with applicable product registrations.
**The CAPSICUM study was supported by the Research Association for Lower Limb Artery Revascularization (LIBERAL) sponsored by the following companies: Boston Scientific Japan K.K., OrbusNeich Foundation, Terumo Corp., and Kaneka Medix Corporation. The funding companies played no role in the design of the study; selection of the enrolled patients; treatment strategy; revascularization procedures or equipment; or collection, analysis, or interpretation of the data.
*** No BSC funding
1. Data on file at Boston Scientific. DRG US hospital market data, June 2024

Featured clinical publications

October 2023

SPORTS RCT

SPORTS is the first investigator-sponsored, core-lab adjudicated, prospective, multi-center, three-arm RCT comparing outcomes of Eluvia DES vs. BMS (investigator choice) vs. Drug-Coated Balloon (DCB) (SeQuent Please), 1:1:1, in TASC C/D lesions.⁵

The Eluvia arm in the SPORTS RCT had an average lesion length of 235mm and is one of the most complex cohorts studied for the stent to date.

Primary endpoint: percentage diameter stenosis in lesion at 12 months⁵

Eluvia DES demonstrated statistically superior performance over BMS, whilst DCB was only non-inferior to BMS when evaluated angiographically for percent diameter stenosis and late lumen loss at 1-year.

Secondary endpoint: freedom from CD-TLR at 12 months⁵

Eluvia DES also demonstrated superior patient outcomes over BMS and DCB as evidenced by freedom from TLR through the 12-month follow-up period.

August 2018

IMPERIAL RCT

IMPERIAL is the first head-to-head Randomized Control (2:1) comparing a polymer-coated, paclitaxel-eluting stent (Eluvia DES) versus polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal lesions up to 140mm in length; multi-center, single-blind; core lab adjudicated.

IMPERIAL RCT 1-year primary patency results

Eluvia DES demonstrated statistically significant difference in primary patency versus Zilver PTX and achieved the highest primary patency reported in any SFA Pivotal Trial at 1-Year.

2-year clinically-driven TLR

Eluvia DES had statistically significant fewer clinically-driven target lesion revascularizations (CD-TLRs) compared to Zilver PTX at 2-Years.⁴

October 2022

EMINENT RCT

EMINENT¹ is the largest Randomized Controlled Trial (RCT) (2:1) comparing Eluvia™ Drug-Eluting Vascular Stent System to self-expanding bare metal stents (BMS) for superficial femoral artery/proximal popliteal artery (SFA/PPA); EU multi-center; superiority trial; core lab adjudicated.

EMINENT RCT 1-year primary patency results

Eluvia DES demonstrated superiority over BMS² with a statistically significant primary patency of 85.4% versus 76.3% through 1-Year.

EMINENT RCT 1-year primary sustained clinical improvement

Eluvia DES demonstrated a statistically significant greater rate of sustained clinical improvement without reintervention over BMS through 1-Year.³

References:

1. EMINENT RCT 1-Year results presented by Yann Gouëffic, MD. VIVA 2021
2. EMINENT Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against commercially-available Self-Expanding Bare Nitinol Stents, single-blind, superiority design; independent core lab adjudication. Primary Endpoint: 1-Year Binary Primary Patency rate of 83.2% in the Eluvia arm vs. 74.3% in the Bare-Metal Stenting arm (p-value = 0.0077).
3. In EMINENT, primary sustained clinical improvement was defined as an improvement (decrease) by at least 1 Rutherford category, without TLR.
4. Gray W. 2-year Outcomes from the IMPERIAL Randomized Head to Head Study of Eluvia DES and Zilver PTX; LINC 2020, Leipzig Jan 28,2020.
5. Tepe G. SPORTS. TCT 2023, October 24, 2023, San Francisco, CA.

Ordering information

Description	UPN	GTIN
Eluvia 6 mm x 40 mm x 130 cm	H74939294600410	08714729876571
Eluvia 6 mm x 60 mm x 130 cm	H74939294600610	08714729876588
Eluvia 6 mm x 80 mm x 130 cm	H74939294600810	08714729876595
Eluvia 6 mm x 100 mm x 130 cm	H74939294601010	08714729876601
Eluvia 6 mm x 120 mm x 130 cm	H74939294601210	08714729876618
Eluvia 6 mm x 150 mm x 130 cm	H74939294601510	08714729876625
Eluvia 7 mm x 40 mm x 130 cm	H74939294700410	08714729876694
Eluvia 7 mm x 60 mm x 130 cm	H74939294700610	08714729876700
Eluvia 7 mm x 80 mm x 130 cm	H74939294700810	08714729876717
Eluvia 7 mm x 100 mm x 130 cm	H74939294701010	08714729876724
Eluvia 7 mm x 120 mm x 130 cm	H74939294701210	08714729876731
Eluvia 7 mm x 150 mm x 130 cm	H74939294701510	08714729876748

Available now in 150mm length. Ask your sales representative about Eluvia 150.

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