Boston Scientific ($BSX) has started a study of its first resorbable, drug-eluting scaffold system to treat atherosclerotic coronary lesions. It incorporates aspects of the company's Synergy System, which has a resorbable polymer and everolimus drug-coating, that the device maker expects will be approved by the FDA during the fourth quarter.
The new prospective, single-arm feasibility study will assess the next-gen scaffold in up to 30 patients; the first patients have been enrolled already at Monash Medical Centre in Melbourne, Australia.
"By virtue of its unique design properties, incorporating thinner struts and enabling greater stent expansion while maintaining radial strength, this fully resorbable scaffold technology may potentially overcome a number of limitations with first generation absorbable scaffolds," Ian Meredith, the study's primary investigator and the director of MonashHeart at the medical center, said in a statement.
The new system is expected to build upon the advances in the Synergy System, which is CE-marked and is one of the cornerstones of Boston Scientific's near-term product approval strategy.
"We are taking the best of our Synergy stent and applying it to our new, fully resorbable scaffold technology," Kevin Ballinger, President of Interventional Cardiology at Boston Scientific, said in a statement. "We continue to invest in meaningful innovations designed to provide better outcomes for patients with coronary artery disease."
Cardiovascular is the best performing group for Boston Scientific--with $712 million in sales last quarter. That was a gain of 10% on a constant currency basis, or 2% on as reported. The company also has Rhythm Management and MedSurg businesses.
- here is the release