Drug-Eluting Vascular Stent System


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 an 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
Results from different trials are not directly comparable.

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 peripheral artery disease.

Sustained Drug Release

Sustained Drug Release

Delivers paclitaxel when restenosis is most likely to occur.

Product Design

Product Design

Built on the proven InnovaTM Stent platform.