IMPERIAL Calcium & CTO – Eluvia Drug-Eluting Vascular Stent

This subgroup analysis provides clinical data on the safety and effectiveness of the Boston Scientific Corporation ELUVIA Drug-Eluting Vascular Stent System for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions in severely and moderately calcified lesions.

Severe/Moderate Calcium Subgroup Analysis Baseline Characteristics

IMPERIAL Calcium Subgroup Kaplan-Meier Primary Patency Rate: 12-Month Results

12-Month Primary Patency Results¹

Eluvia demonstrated 89.2% primary patency in severely and moderately calcified lesions in the IMPERIAL Calcium Subgroup²

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.

2. Versus 87.0% primary patency in the none/mild calcium arm of the IMPERIAL Calcium subgroup.

IMPERIAL CTO Subgroup Analysis

Objective

CTO Subgroup Baseline Characteristics

IMPERIAL CTO Subgroup Kaplan-Meier Primary Patency Rate: 12-Month Results

12-Month Primary Patency Results³

Eluvia demonstrated 83.9% primary patency in completely occluded lesions in the IMPERIAL CTO Subgroup⁴

3. Kaplan Meier Estimate; Primary patency defined as duplex ultrasound PSVR ≤2.4, in the absence of clinically-driven target lesion revascularization or bypass of the target lesion, as assessed by the DUS core lab.

2. Versus 90.6% in the non-CTO arm of the IMPERIAL subgroup.