|Boston Scientific is awaiting FDA clearance for the OffRoad catheter.--Courtesy of Boston Scientific|
Boston Scientific's ($BSX) in-development device to treat arterial blockages posted strong results in an FDA-targeted study, helping physicians navigate clogged vessels and restore blood flow.
The OffRoad catheter system is designed to get around occlusions in major arteries that supply blood to the legs, treating blockages associated with peripheral artery disease. In a study of 92 patients, the device posted an 84.8% success rate, above Boston Scientific's pre-specified goals, and the trial found 75% of patients to have reduced their PAD severity scores after 30 days.
Boston Scientific hopes those results will convince the FDA to clear the already CE marked system, adding another revenue-generating device to Boston Scientific's growing peripheral interventions business, segment President Jeff Mirviss said.
"Peripheral artery disease can be debilitating, and Boston Scientific is committed to working with physicians and hospital systems to bring forward innovative technologies and science that lead to better outcomes for patients worldwide," 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.
Expanding Boston Scientific's catheter offerings is one facet of CEO Mike Mahoney's plan to reverse the company's fortunes, dovetailing with a focus on emerging markets, thousands of job cuts and a fair amount of M&A.
- read the announcement