Boston Scientific aims for FDA approval with absorbable stent trial
|Boston Sci enrolled its first patient in a trial designed to get the Synergy stent approved in the U.S. and Japan--courtesy of Boston Scientific|
Boston Sci is targeting FDA and Japanese approval with the trial, which will involve up to 2,000 patients at about 160 sites around the world, the company says.
Synergy is designed to treat atherosclerotic coronary lesions by propping open the artery and emitting everolimus into the vessel. What separates the device from other offerings, however, is its bioabsorbable coating, which Boston Sci says melts away harmlessly once the drug content is spent, leaving just the bare-metal stent and significantly reducing rates of polymer-related adverse events.
Boston Sci is in the process of crawling out of a sales hole for its interventional cardiology business, which includes stents. Last quarter, the unit's revenue plummeted 20% to $494 million from $613 million the year before.
However, Kevin Ballinger, the division's president, said innovative devices such as Synergy will help Boston Sci carve out a greater market share.
"We continue to strengthen our drug-eluting stent portfolio with innovations like the Synergy system in an effort to increase the advanced treatment options available to physicians and patients," Ballinger said in a statement.
Abbott Laboratories ($ABT) has a related device, the Absorb, which it launched in CE mark countries in September, but the company hasn't disclosed a timeframe for an FDA application.
- read Boston Sci's announcement