Boston Scientific's Eluvia Peripheral Drug-Eluting Stent Gains FDA Approval
September 24, 2018—Boston Scientific has announced US FDA approval of its Eluvia drug-eluting vascular stent system for use in peripheral artery disease. Earlier this week, results from the IMPERIAL trial were simultaneously published in The Lancet and presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Diego, California, and the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) congress in Lisbon, Portugal.
The IMPERIAL trial randomized treatment using Eluvia in a 2:1 fashion against Cook Medical's Zilver PTX device, previously the only approved peripheral drug-eluting stent (DES) in the United States. As announced at TCT and CIRSE, Eluvia successfully met its noninferiorty endpoint and showed superior results in the head-to-head trial. As summarized in the company's announcement, patients treated with Eluvia saw a significantly greater 12-month primary patency rate of 88.5% compared to 79.5% for those in the Zilver PTX arm (P = 0.0119).
More information from the presentations and publication of IMPERIAL can be seen here.
"In the IMPERIAL trial, the Eluvia stent demonstrated landmark vessel patency and freedom from target lesion revascularization rates, preventing more than 95% of patients from needing a reintervention after 1 year," commented William Gray, MD, System Chief, Division of Cardiovascular Diseases and President, Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania, in Boston Scientific's announcement. Dr. Gray is the Coprincipal Investigator of the IMPERIAL trial and presented the 1-year data at TCT. "The Eluvia stent is a breakthrough therapy that marks a significant step forward in the treatment of peripheral artery disease, and now with its approval and commercial availability, it has the potential to make an immediate impact on the quality and value of care that physicians can provide to their patients."