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ELUVIA VS. BARE METAL STENTS

EMINENT randomised controlled trial results

Eminent Clinical Trial Results

EMINENT3 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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EMINENT RCT 1-year primary patency results

Eluvia demonstrated superiority over BMS1 with a statistically significant primary patency of 85.4% versus 76.3% through 1-Year.

1-Year Primary Kaplen Meijer Patency estimate

Eluvia demonstrated a statistically significant greater rate of sustained clinical improvement without reintervention over BMS through 1-Year.6

EMINENT RCT 1-year primary sustained clinical improvement

EMINENT Trial Eluvia 1 Year Primary Sustained

EMINENT randomised controlled trial details

  Eluvia DES
(n=492)		 BMS 
(n=273)		 p-value
All Death, Major Amputation, TLR 11.8% (56/474) 11.8% (31/263) 0.9912
All-Cause Death at 1-Year 2.7% (13/474) 1.1% (3/263) 0.1528
Target Limb Major Amputation 0.2% (1/474) 0.0% (0/263) 1.0000
Clinically-Driven Target Lesion Revascularization 8.4% (40/474) 10.6% (28/263) 0.3212
  Eluvia DES
(n=508)		 Control 
(n=267)		 p-value
Age (Years) 68.9 ± 8.7  68.9 ± 9.1 0.9739
Male Gender 71.5% 67.4% 0.2431
Diabetes Mellitus (medically-treated) 31.9% 32.6% 0.8440
History of Smoking (current/previous) 36.0% / 39.6% 36.0% / 41.6% 0.9849 / 0.5884
Percent Stenosis (%) 86.6 ± 15.2 85.5 ± 15.3 0.3629
Total Occlusions 42.3% 39.9% 0.5372
Total Stented Length (mm) 105.8 ± 48.4 109.2 ± 49.8 0.3858
Target Lesion Length (mm) 75.6 ± 50.3 72.2 ± 47.0 0.3815
Moderately Calcified 21.6% 26.0% 0.1849
Severely Calcified 30.3% 31.1% 0.8122

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1. 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. EMINENT RCT 1-Year results presented by Yann Gouëffic, MD. VIVA 2021

4. Kaplan-Meier Estimate: Primary patency defined as core-lab assessed duplex ultrasound peak systolic velocity ratio (PSVR) ≤ 2.4 at 1-year in the absence of clinically-driven TLR or bypass of the target lesion.

5. Log-rank p-value compares the entire K-M curves from time point zero to day 395 (full 1-year follow-up window)

6. In EMINENT, primary sustained clinical improvement was defined as an improvement (decrease) by at least 1 Rutherford category, without TLR.

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.