FDA Approves Marketing For Boston Scientific's Artery Device

MARLBOROUGH, MA—Boston Scientific, medical giant with its headquarters in Marlborough, just got approval on Monday from the FDA to market the Eluvia Drug-Eluting Vascular Stent System.

The system was developed for the treatment of peripheral artery disease.

"The Eluvia stent utilizes a drug-polymer combination to offer sustained release of the drug paclitaxel for a one-year timeframe, designed to prevent tissue regrowth that might otherwise block the stented artery," said the release.

Boston Scientific reported that approximately 8.5 million people in the United States are affected by PAD, which occurs when plaque builds up on the walls of the arteries of the legs, restricting blood flow and causing pain, swelling and a diminished quality of life.

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."

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