ELUVIA™

Drug-Eluting Vascular Stent System

Superior Results in the first head-to-head DES SFA Trial<sup>1</sup>

*Kaplan-Meier Primary Patency Estimate through 1-year (including follow-up window) was statistically significant with a p-value of 0.0094.

1. Kaplan Meier Estimate; Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.

The Eluvia Drug-Eluting Stent System showed SUPERIOR results in the first head-to-head DES SFA Trial.


IMPERIAL Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against Cook Medical’s Zilver™ PTX™ Stent, single-blind, non-inferiority design; independent core lab adjudication.
Superiority determined in a post hoc analysis that was specified prior to unblinding. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).

Objective

Evaluate the safety and effectiveness of the Boston Scientific Corporation ELUVIA™ Drug-Eluting Vascular Stent System for treating SuperficialFemoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions up to 140 mm in length.

IMPERIAL Trial Design

Global multi-center, 2:1 randomization against Cook Medical’s Zilver™ PTX™ Stent, controlled, single-blind, non-inferiority trial; core lab adjudicated.

  • 465 (RCT) patients across 64 sites
  • 5-year follow-up
  • Degree of stenosis ≥ 70% (visual angiographic assessment)
  • Vessel diameter ≥ 4 mm and ≤ 6 mm
  • Total lesion length ≥ 30 mm and ≤ 140 mm

Baseline Characteristics

PATIENT DEMOGRAPHICS ELUVIA™
(n=309)
Zilver PTX™
(n=156)
Age (Years) 68.5±9.5 67.8±9.4
Male Gender 66.0% 66.7%
Diabetes Mellitus 41.7% 43.6%
History of Smoking 86.1% 84.0%
 
LESION CHARACTERISTICS ELUVIA™
(n=309)
Zilver PTX™
(n=156)
Target Lesion Length (mm) 86.5±36.9 81.8±37.3
Severely Calcified 40.1% 32.3%
Total Occlusions 31.2% 30.3%
Extending into Distal SFA 66.3% 65.4%
 

12-Month Primary Patency Results

Eluvia demonstrated a statistically significant difference in primary patency and half the TLR rate vs. Zilver PTX at 12 months.
IMPERIAL Clinical Trial Kaplan-Meier Primary Patency Rates and TLR chart
In IMPERIAL RCT and as reported in The Lancet, 1-year ITT, CEC adjudicated mortality rates were 2.1% (6/292) for Eluvia and 4.0% (6/150) for Zilver PTX (p=0.23).
*Kaplan Meier Estimate; Primary patency as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) is ≤ 2.4 at the 12-month follow-up visit, in the absence of clinically-driven TLR or bypass of the target lesion.
** Gray, WA TCT 2018.
† Log-rank p-value compares the entire K-M curves from time zero to full one year follow-up window.
1. IMPERIAL Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against Cook Medical’s Zilver™ PTX™ Stent, single-blind, non-inferiority design; independent core lab adjudication.Superiority determined in a post hoc analysis that was specified prior to unblinding. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
Product Overview

Product Overview

Advanced drug-eluting technology for peripheral artery disease.

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Sustained Drug Release

Sustained Drug Release

Delivers paclitaxel when restenosis is most likely to occur.

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Product Design

Product Design

Built on the proven InnovaTM Stent platform.

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