24-Month Primary Patency Results

Eluvia demonstrated the highest ever 2-year primary patency in an SFA pivotal trial1

 

1. Highest two-year primary patency based on 24-month Kaplan-Meier estimates reported for IMPERIAL, IN.PACT SFA, ILLUMENATE, LEVANT II and Primary Randomization for Zilver PTX RCT.
* Intention to treat. Kaplan-Meier estimate utilizing time-to-event of clinically-driven TLR up to 730 days and Duplex Ultrasound data at 24 months. 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.

24 month chart
Kaplan-Meier Primary Patency Rate: 12-Month Results chart

IMPERIAL Trial RCT Full Cohort 12-Month Results

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12-Month Primary Patency Results3

Eluvia demonstrated a statistically significant difference in primary patency compared to Zilver PTX at 12 months in the IMPERIAL Trial.

3. 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.

IMPERIAL 12-Month Severe/Moderate Calcium Subgroup Analysis

12-Month Primary Patency Results1

89.2% primary patency in severe and moderately calcified lesions2

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. 

12-month Kaplan-Meier Estimate Primary Patency Rate
 
12-month Kaplan-Meier Estimate Primary Patency Rate

IMPERIAL 12-Month Diabetic Subgroup Analysis

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12-Month Safety Results

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

Kaplan-Meier Primary Patency Rate: 12-Month Results chart

IMPERIAL 12-Month Long Lesion Sub-Study

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12-Month Primary Patency Results4

Eluvia demonstrated a 87.9% primary patency in the IMPERIAL Long Lesion Sub-Study.

4. 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.

IMPERIAL Clinical Trials
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