Drug-eluting stent approved for PADDecember 13, 2018
Boston Scientific Corporation’s drug-eluting vascular stent system, specifically developed for the treatment of peripheral artery disease (PAD), has been approved by the US FDA.
The Eluvia stent utilizes a drug-polymer combination to provide sustained release of the drug paclitaxel for a one-year timeframe. It is designed to prevent tissue regrowth that might otherwise block the stented artery.
The approval was based on findings from the IMPERIAL trial, the first superficial femoral artery head-to-head drug-eluting stent trial evaluating the safety and efficacy of Eluvia vs Zilver PTX in 465 patients.
The results of the trial showed that 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.
The Eluvia stent system is built on the Innova Stent System platform, a self-expanding nitinol stent that has been designed for use in the superficial femoral and proximal popliteal arteries, the main arteries that supply blood to the legs.