Eluvia provides consistent, durable outcomes in challenging SFA disease and features a polymer design for controlled drug release.
Exceptional Outcomes vs Zilver™ PTX™In the IMPERIAL Trial, Eluvia demonstrated a statistically significant difference in primary patency and half the TLR rate vs. Zilver PTX at 12 months1.
- 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).
*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.
Exceptional Outcomes at 2 Years
At 2 years, Eluvia demonstrated the highest primary patency ever reported in an SFA US Pivotal Trial for DES or DCB2 and a statistically significant reduction in TLR vs. Zilver™ PTX™.
- 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.
"We were hoping that we would see a device that would allow us to tell our patients that we would have mid-80% patency at 24 month follow-up."
Hear Dr. Robert Lookstein's Commentary on Eluvia's 2-Year Data
Robert Lookstein, MD
Mount Sinai Medical Center
New York, NY
As the only device using polymer to elute drug for PAD, Eluvia features the lowest drug does density among all peripheral paclitaxel-based technologies.
Eluvia’s polymer ensures targeted delivery of the drug to the lesion and minimizes downstream particulates.
Eluvia showed similar particulate loss compared to a bare metal stent
- Devices were tested in simulated-use conditions with fluid recirculation. Media was collected using 5 μm pore size filters and imaged at 50x magnification.
IMPERIAL Pharmacokinetic Sub-study
In the IMPERIAL Pharmacokinetic Sub-study, paclitaxel from Eluvia was undetectable in the plasma after 10 minutes4
- Eluvia PK results from Boston Scientific data on file. Paclitaxel plasma concentrations measured at 10 and 30 minutes and 1, 2, 3, 4, 6, 12, 24 and 48 hours post-implant.
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