Reva Medical (ASX:RVA) said yesterday it won CE Mark approval in the European Union for its Motiv bioresorbable drug-eluting scaffold, now cleared for treatment of below-the-knee peripheral artery disease.
The San Diego-based company’s Motiv is made from the company’s proprietary radiopaque Tyrocore polymer designed for vascular scaffolds. Reva said that over the coming months, it will select centers to analyze the device’s performance and for other possible future applications.
“Reva did not just achieve its own milestone with CE Mark of Motiv, we achieved a therapeutic milestone for patients with critical limb ischemia. Tyrocore and our polymer technology have a broad range of therapeutic applications. This is our first step beyond the coronary arteries, and we look forward to bringing a new treatment option to peripheral artery disease patients and their physicians,” CEO Reggie Groves said in a prepared statement.
The company expects the device to be used in its first commercial case late this year, or early in 2019.
Earlier this month, Reva said that it inked a deal with Bio Vascular Group to distribute Reva’s Fantom bioresorbable scaffold in Italy.
