ELUVIA™ Drug-Eluting Vascular Stent System
Design & Dose
Eluvia is the only peripheral device that uses a polymer for controlled drug delivery of the lowest drug dose.
Adding to the current dialogue about paclitaxel in PAD, Dr. Robert Lookstein shares commentary on Eluvia.
Eluvia has the lowest drug dose density among all peripheral paclitaxel-based technologies
Eluvia’s controlled drug delivery ensures that the majority of drug is transferred to the lesion rather than downstream
Eluvia has been shown to be endothelialized within 90 days post-implant2
1. Peter A. Schneider, MD, LINC 2017
2. Internal preclinical testing data on file.
2-year results from IMPERIAL, the world’s first head-to-head DES SFA Trial1
Presented at LINC 2020
Eluvia demonstrated the highest primary patency ever reported in an SFA US Pivotal Trial for DES or DCB*
* 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.
1. IMPERIAL Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against Cook Medical’s Zilver™ PTX™ Stent, single-blind, non-inferiority design; independent core lab adjudication. Superiority determined in a post hoc analysis that was specified prior to unblinding. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
2. In IMPERIAL RCT, Eluvia K-M Primary Patency was 83% vs. 77.1% for Zilver PTX at 24 months, p=0.1008.
** 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.
1. IMPERIAL Trial: A global randomized controlled multi-center trial with 2:1 randomization of the Eluvia™ Drug-Eluting Stent against Cook Medical’s Zilver™ PTX™ Stent, single-blind, non-inferiority design; independent core lab adjudication. Superiority determined in a post hoc analysis that was specified prior to unblinding. 12-Month Primary Patency rate of 86.8% in the Eluvia arm vs. 77.5% in the Zilver PTX arm (p-value = 0.0144).
2. In IMPERIAL RCT, Eluvia K-M Primary Patency was 83% vs. 77.1% for Zilver PTX at 24 months, p=0.1008.
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