Regulators in the United States have approved the Eluvia Drug-Eluting Vascular Stent System (Boston Scientific) for the treatment of peripheral artery disease (PAD), based on the paclitaxel-polymer-based stent"s showing in the IMPERIAL trial, the company announced today.
The US Food and Drug Administration approval follows IMPERIAL"s presentation at Transcatheter Cardiovascular Therapeutics 2018 and its publication in the Lancet released at about the same time, both covered bytheheart.org | Medscape Cardiology.
Patency rates at one year for the treated femoropopliteal arteries in the trial were noninferior for the Eluvia stent compared with stenting with the paclitaxel-eluting Zilver PTX (Cook Medical). The actual 12-month patency rate difference between the two stents emerged as significantly greater for Eluvia in a prespecified post hoc analysis (P < .001).
In contrast to the Zilver, the Eluvia system is designed to delivery a polymer vehicle for paclitaxel that delivers the drug gradually over the course of a year. It received CE-Mark approval in Europe about 2 years ago, Boston Scientific says in their press release.