|Boston Scientific is launching an overseas study of the Innova drug-eluting stent.--Courtesy of Boston Scientific|
Boston Scientific ($BSX) is looking to get in on the market for drug-eluting stents for peripheral artery disease, launching an overseas study with eyes on CE mark.
The company is testing a paclitaxel-emitting version of its Innova stent on 55 patients in Europe, Australia and New Zealand, betting that the self-expanding device can successfully treat lesions in the superficial femoral artery. Innova DES uses a novel low-profile delivery system to prop open the arteries above the knee, and it's designed to navigate challenging anatomies with lower risk of stent fracture or restenosis, the company said.
The device builds off the success of the bare-metal Innova, a CE marked stent for which Boston Scientific is seeking FDA approval. Only Cook Medical has a U.S.-approved drug-eluting stent for peripheral artery disease in its Zilver PTX.
For Boston Scientific, the investigational device would expand its access to the world's 27 million PAD sufferers and drive revenue for the company's still-recovering peripheral interventions business, unit President Jeff Mirviss said.
"The Innova DES system builds upon the Boston Scientific leadership in both peripheral vascular devices and drug-eluting technologies, and we look forward to bringing this meaningful innovation forward to improve outcomes for patients with PAD," Mirviss said in a statement.
Peripheral devices were among the lone bright spots for Boston Scientific last quarter, growing 2% to $199 million while larger businesses like cardiovascular devices and rhythm management slipped by single digits, contributing to a 1% overall sales decline.
A deeper dive into peripheral interventions is part of CEO Mike Mahoney's plan to reverse Boston Scientific's long-declining fortunes, combining a focus on emerging markets, thousands of job cuts and a fair amount of M&A.
- read the statement