"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 ›
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 Safety Results*:
- 85.8% of Eluvia patients were free from Major Adverse Events at 24 months (vs. 79.9% of Zilver PTX patients)
- All-cause mortality for Eluvia was 7.1% (21/295) vs. 8.3% (12/145) for Zilver PTX (p=0.6649)
* Intention to treat. Clinical Events Committee-adjudicated adverse events included major adverse events (MAE), all deaths, and stent thrombosis. MAEs defined as all causes of death through 1 month, target limb major amputation through 24 months, and target lesion revascularization through 24 months.
New Eluvia 2-year clinically-driven TLR data show very low revascularization rates with polymer-based delivery.
24-Month All-Cause Mortality
Adapted from Iida, O, VIVA 2019 Presentation
*Amputation Rates, Mortality, and Preoperative Comorbidities in Patients Revascularised for Intermittent Claudication or Critical Limb Ischaemia: A Population Based Study Baubeta Fridh, E. et al. European Journal of Vascular and Endovascular Surgery , Volume 54 , Issue 4 , 480 486
5-Year Data with Polymer-Based Coronary Paclitaxel Devices
As a polymer-based drug eluting stent, Eluvia is more like coronary stents, such as Boston Scientific's TAXUS, versus peripheral paclitaxel-coated products. Both Eluvia and TAXUS deliver the same drug and are similar in design intent and mechanism of action; both yielding sustained, targeted paclitaxel delivery.
As published in JACC:CI, TAXUS demonstrated a 9.8% all-cause mortality rate at 5 years, compared to 9.1% in the BMS arm (p-value = 0.53)
A 5-year patient-level pooled meta analysis
from randomized, controlled trials, published in JACC:CI, from 2,797 patients (TAXUS DES vs. BMS) showed no difference in mortality
5 year data in PAD patients
(TAXUS DES vs PTA + BMS) showed no difference in mortality in CLI
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