Eluvia Drug-Eluting Vascular Stent System

Remarkable and Consistent Primary Patency Even in Challenging Lesions

 

IMPERIAL Severe/Moderate Calcium Subgroup Analysis

Objective

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

Calcium Patient Demographics
Calcium Lesion 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 Calcium Subgroup Kaplan-Meier Primary Patency Rate: 12-Month Results
12-Month Primary Patency Results

 

IMPERIAL CTO Subgroup Analysis

Objective

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 Chronic Total Occlusions (CTOs).

 

CTO Subgroup Baseline Characteristics

CTO Patient Demographics
CTO Lesion 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.

 

 

 


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

 

 

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