Eluvia Drug-Eluting Vascular Stent System

TLR reduction of greater than 70% in a challenging diabetic patient population.

Eluvia has the lowest drug dose density of available drug-eluting technologies at 0.167 μg/mm2.

Hear IMPERIAL Principal Investigator, William Gray, MD

Hear IMPERIAL Principal Investigator, William Gray, MD share his perspectives on what the data means for diabetic patients.

IMPERIAL Diabetic 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 the Diabetic patient population.

 

Diabetic Subgroup Baseline Characteristics

Patient Demographics
Lesion Characteristics

 

 

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

 

12-Month Primary Patency Results1

Eluvia demonstrated 87.4% primary patency versus 80.2% for Zilver PTX in the IMPERIAL Diabetic Subgroup.

 

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.

 

 

 

 

 

12-Month TLR Rate

Eluvia demonstrated a statistically significant reduction in TLR of greater than 70% in diabetic patients.

Eluvia demonstrated a statistically significant reduction in TLR of greater than 70% in diabetic patients
Zilver PTX 8.1% vs ELUVIA 0.9%

 

Eluvia demonstrated a 9-fold, statistically significant lower stent thrombosis rate compared to Zilver PTX in diabetic patients.



 

Eluvia has demonstrated remarkable and consistent primary patency

 


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