Marlborough medical device giant Boston Scientific has been approved by U.S. regulators to market a device that helps deliver a sustained release of a drug to treat peripheral artery disease.
The U.S. Food and Drug Administration approved the company’s Eluvia Drug-Eluting Vascular Stent System, which uses a drug-polymer combination to provide sustained release of the drug paclitaxel for a year.
FDA approval follows a two-year trial that found the Eluvia stent demonstrated superior results than the company’s Indiana-based competitor Cook Medical, which offers a similar device.
In the trial, patients treated with Boston Scientific’s device experienced a greater 12-month primary patency of 88.5 percent compared to 79.5 percent in patients treated with Cook Medical’s device.
