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Caution: Eluvia is an investigational device. Limited by US law to investigational use only. Not available for sale.

Global Investment in Drug-Eluting Technologies

Boston Scientific’s global investment in drug-eluting technologies included testing 3,500 patients Boston Scientific’s global investment in drug-eluting technologies included testing 3,500 patients
Boston Scientific’s global investment in drug-eluting technologies included 20+ clinical trials Boston Scientific’s global investment in drug-eluting technologies included 20+ clinical trials
Boston Scientific’s global investment in drug-eluting technologies included studies of two platforms. Boston Scientific’s global investment in drug-eluting technologies included studies of two platforms.
Dr. Stefan Müller-Hülsbeck discusses the unprecedented clinical data for the Eluvia Stent

“Most impressive and surprising have been the data…we achieved at two years a primary patency rate of 83.5%.”

Stefan Müller-Hülsbeck, MD
Principal Investigator, MAJESTIC Trial
Vascular Center Diako | Flensburg, Germany

Clinical Results for the Eluvia Drug-Eluting Stent

MAJESTIC 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 

Lesion Characteristics

(Core Lab)

n = 57 

lesions

Reference Vessel Diameter  5.2 ± 0.8
Target Lesion Length 70.8 ± 28.1
Severely Calcified 64.9%
Percent Diameter Stenosis  86.3% ± 16.2%
Total Occlusions 46.2%
% Extending into Distal SFA 77.2%
% Extending into PPA 8.8%

Chart showing the MAJESTIC 2-year primary patency rate for the Eluvia Drug-Eluting Vascular Stent is 83.5%

MAJESTIC 1- and 2-Year Primary Patency


Chart showing the MAJESTIC 2-year primary patency rate for the Eluvia Drug-Eluting Vascular Stent is 83.5%

MAJESTIC Trial 2-Year Results


2-Year Patient Outcomes


  • 91% of patients sustained clinical improvement through 2 years
  • 91% of patients presented with no or minimal claudication at 2 years

Rutherford Category


Chart showing the 36-month freedom from TLR in patients with the Eluvia Drug-Eluting Vascular Stent is 85.3%

Chart showing the TLR-free rate in challenging lesions in patients with the Eluvia Drug-Eluting Stent.

Sub-Analysis: TLR-Free Rate in Challenging Lesions
Kaplan-Meier Estimate


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