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
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
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
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.
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