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.”
Here’s some data from the IMPERIAL trial, according to Boston Sci:
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. In this trial, patients treated with the Eluvia stent experienced a significantly greater 12-month primary patency of 88.5 percent, compared to 79.5 percent in patients treated with Zilver PTX (p=0.0119). In addition, patients treated with the Eluvia stent experienced half the target lesion revascularization rate of Zilver PTX at 12 months, a 4.5 percent TLR rate for Eluvia versus 9.0 percent TLR rate for the Zilver PTX cohort.
Here are a couple videos Boston Scientific just released about the stent:
Product page: ELUVIA drug-eluting vascular stent system…
Via: Boston Scientific…