ELUVIA™

Drug-Eluting Vascular Stent System

Objective

To evaluate the performance of the Eluvia Drug-Eluting Vascular Stent System in the treatment of superficial femoral (SFA) and/or proximal popliteal artery (PPA) lesions.

Trial Design

  • Eligible patients with chronic, symptomatic (Rutherford categories 2, 3 or 4) lower limb ischemia and stenotic, restenotic or occlusive lesions in the native superficial femoral artery or proximal popliteal artery (n=57)
  • Degree of stenosis ≥ 70% (visual angiographic assessment)
  • Vessel diameter ≥ 4 and ≤ 6mm
  • Total lesion length ≥ 30 mm and ≤ 110 mm 

Baseline Characteristics

Patient Demographics n = 57 subjects Lesion Characteristics
(Core Lab)
n = 57 lesions
Age (Years) 69.3 ± 9.3 Reference Vessel Diameter  5.2 ± 0.8
Male Gender 82.5% Target Lesion Length 70.8 ± 28.1
Diabetes Mellitus 35.1% Severely Calcified 64.9%
History of Smoking  87.7% Percent Diameter Stenosis  86.3% ± 16.2%
Hypertension 73.7% Total Occlusions 46.2%
Hyperlipidemia 63.2% % Extending into Distal SFA 77.2%
Coronary Artery Disease 38.6% % Extending into PPA 8.8%
  

2-year Eluvia Clinical Results

The Eluvia Drug-Eluting Stent System continues to demonstrate unprecedented clinical outcomes with a 83.5% primary patency at 2 years, the highest reported in comparable SFA clinical trials.1 Review the Eluvia Majestic results on the graph below.

Freedom from TLR curve

Safety Results

  • 7.5% composite major adverse event rate at 2 years
  • 4 TLR events (4/53)

Stent Integrity

  • No stent fractures at 2 years upon angiographic core lab analysis

Patient Outcomes

  • 91% of patients presented with no or minimal claudication at 2 years
  • 91% of patients sustained clinical improvement through 2 years
  • ABI improvement sustained through 2 years (0.94±0.22)
Majestic Trial 12-month Results Rutherford Category for ELUVIA SFA drug-eluting stents (DES).
Product Overview

Product Overview

Advanced drug-eluting technology for PAD.

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Sustained Drug Release

Sustained Drug Release

Delivers paclitaxel when restenosis is most likely.

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Product Design

Product Design

Built on the proven InnovaTM Stent platform.

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