USA – Boston Scientific’s Eluvia Peripheral Long Term Drug Eluting Stent FDA Approved

Boston Scientific won FDA regulatory approval to introduce the Eluvia drug-eluting vascular stent to the U.S. market. The device is the first peripheral stent to offer sustained release of an antiproliferative drug (paclitaxel) for as long as a full year. The drug prevents restenosis, a common condition caused by native tissue growing over the stent.

The Eluvia is based on Boston Scientific’s Innova device, which is a self-expanding nitinol stent built to treat superficial femoral and proximal popliteal arteries in the legs.

“In the IMPERIAL trial, the Eluvia stent demonstrated landmark vessel patency and freedom from target lesion revascularization rates, preventing more than 95 percent of patients from needing a reintervention after one year,” in a statement said William Gray, M.D., system chief, Division of Cardiovascular Diseases and president, Lankenau Heart Institute at Main Line Health in Wynnewood, Pennsylvania, and co-principal investigator of the IMPERIAL trial that led to the FDA approval. “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.”…