Wednesday, November 30, 2011

Boston Scientific gets FDA OK for three defibrillators

By Michelle Lang

The U.S. Food and Drug Administration has granted a total of three approvals to Natick medical devices company Boston Scientific Corp. for devices targeting treatment of heart failure and sudden cardiac death. The devices – Incepta, Energen and Punctua cardiac resynchronization therapy defibrillators (CRT-Ds) and implantable cardioverter defibrillators (ICDs) – have already seen their first implant with the Incepta ICD at the University of Washington Medical Center in Seattle.

Boston Scientific (NYSE: BSX) noted in a news release that the three defibrillators are designed for small, thin platforms, due to its DF4 universal connector system, and have a longer-lasting battery. They also incorporate Boston Scientific’s Latitude Heart Failure Management system – a weight scale and blood pressure cuff sensors – as an option meant to enable remote monitoring for doctors and patients.

The company won FDA approval last week for its drug-eluting stent, the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System, which Boston Scientific said it plans to market in the U.S. immediately.