Reva Medical received a CE mark for a new drug-eluting bioresorbable scaffold, which it described as the first device of its type to receive approval for the treatment of below-the-knee peripheral artery disease. The San Diego-based company expects to see its use in patients in late 2018 or early next year.
The approval of the MOTIV scaffold also represents the company’s first move into the peripheral artery disease space. Over the next few months, Reva plans to select a number of centers to assess the scaffold’s performance and determine the future of its commercial strategy in peripheral vascular indications.
“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,” Reva CEO Reggie Groves said in a statement.
The move comes a year after Boston Scientific decided to shut down its Renuvia bioresorbable stent program, following the series of setbacks that Abbott saw in the sector compared to the newest metallic drug-eluting stents.
MOTIV is made from Reva’s radiopaque polymer, Tyrocore, which is derived from naturally occurring tyrosine amino acid and is visible under x-ray fluoroscopy to ensure accurate placement within the artery. The scaffold is coated with antiproliferative and immunosuppressive drug sirolimus.
The company’s lead products include the Fantom and Fantom Encore bioresorbable scaffolds for coronary artery disease, also made with Tyrocore. The Encore product line, with a thinner strut profile, recently received (PDF) CE mark approval for new diameters of 3.0 and 3.5 mm, in addition to the previously approved 2.5-mm scaffold.
Reva first received a CE mark for its Fantom line in April 2017, based on data from 117 patients. Including results from a later 123-patient cohort, the company saw a 2.1% rate of major adverse cardiac events after six months, with a mix of heart attacks, cardiac deaths and revascularizations occurring either in the hospital or toward the end of the time window.
Two-year data unveiled in May (PDF) showed a 5.0% rate of major adverse cardiac events with Fantom and a single scaffold thrombosis event for a rate of 0.4%, the company said.