The FDA's approval is based on findings from the IMPERIAL trial, in which the Eluvia stent demonstrated superior results in the first superficial femoral artery head-to-head drug-eluting stent trial. 2 In this trial, patients treated with the Eluvia stent experienced a significantly greater 12-month primary patency of 92.1 percent, compared to ...
• 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) CONSISTENTLY LOW 2-YEAR CD-TLR IN CHALLENGING SFA DISEASE 2-Year Results: In IMPERIAL RCT, Eluvia demonstrated a statistically significant
MARLBOROUGH, Mass., Sept. 28, 2015 /PRNewswire/ -- New 12-month clinical trial outcomes assessing the safety and performance of the Boston Scientific (NYSE: BSX) Eluvia™ Drug-Eluting Vascular Stent System reflect a primary patency rate 1 of more than 96 percent. These results represent the highest 12-month primary patency reported for …
MARLBOROUGH, Mass., Feb. 22, 2016 /PRNewswire/ -- Boston Scientific (NYSE: BSX) today announced that the Eluvia™ Drug-Eluting Vascular Stent System has received CE Mark and is commencing commercialization immediately in the European Union and other countries where CE Mark is recognized. The Eluvia Stent System is designed to restore …
The Eluvia drug-eluting vascular stent system (Boston Scientific, MA, USA) was designed with a biocompatible fluoropolymer coating to allow for drug elution over time. Initial clinical results demonstrate promising efficacy in terms of sustained femoropopliteal artery patency along with a good safety profile. This review summarizes the existing ...
The Eluvia™ stent was designed to perform in the unique environment of the SFA. Its polymeric coating allows for pacli-taxel elution over a long period of time to overlap the timeline associated with peripheral arterial restenosis. The available preclinical and clinical data on treatment with Eluvia™suggest
Eluvia™ is the first polymer-based, drug-eluting stent designed to treat and restore blood flow in the peripheral arteries above the knee specifically the – superficial femoral artery (SFA) and proximal popliteal artery (PPA)the . The Eluvia Stent System utilises the anti-restenotic drug paclitaxel in conjunction with a polymer.
When asked why Eluvia would provide better results relative to Zilver PTX, Gray said that Eluvia was purpose-built for SFA interventions, whereas Zilver PTX was not as specifically directed toward the SFA. Also, the devices deliver paclitaxel in different ways: Zilver PTX releases the drug rapidly over the course of about 2 months and Eluvia ...
Background Although several clinical reports demonstrated a durable patency rate after a novel fluoropolymer-coated paclitaxel-eluting stent (Eluvia; Boston Scientific, Marlborough, MA, USA) placement, aneurysmal degeneration after drug-eluting stent (Eluvia) placement has raised clinical concerns. Here, we report a case with progressive …
Purpose: This multicenter, prospective, observational study aimed to compare Zilver PTX and Eluvia stents in real-world settings for treating femoropopliteal lesions as the differences in the 1-year outcomes of these stents have not been elucidated. Materials and methods: Overall, 200 limbs with native femoropopliteal artery disease were treated with …
Eluvia™ was developed to counter this peak in the restenotic cascade – and is the only drug-eluting stent to offer a sustained release of paclitaxel (PTX) that extends to the critical 12-month timepoint. While other DES may only elute PTX for 2-3 months, Eluvia continues to fight restenosis when the risk is at its highest.