Thursday, February 5, 2009

Boston Scientific wraps up application for FDA OK of new stents

By Mass High Tech staff

Medical devices company Boston Scientific Corp. reports it has submitted the final modules to the U.S. Food and Drug Administration for the company’s Pre-Market Approval applications for a pair of its coronary stent systems.

Natick-based Boston Scientific (NYSE:BSX) submitted the modules for both its Taxus Liberte Atom paclitaxel-eluting coronary stent system and its Taxus Liberte Long paclitaxel-eluting coronary stent system. If approved, the Taxus Liberte Atom would likely replace the Taxus Express Atom stent, which is the company’s first approved small stent to treat small vessels.

These submissions include clinical data from global, multi-center studies, designed to compare the performance of the new stents with Boston Scientific’s first-generation Taxus Express stent. The second-generation Taxus Liberte Stent is identical in drug dose, polymer and release kinetics as the earlier model, but it is specifically designed for drug delivery, according to company officials.

Earlier this week, Boston Scientific reported it had started enrolling patients in its Platinum clinical trial to test the company’s Promus Element Everolimus Coronary Stent. With two patients enrolled last week in the U.S. and Japan, the trial is expected to test about 1,728 people at 160 global facilities, and it should be fully enrolled by October.

The tests will compare the Promus Element Everolimus Coronary Stent and the existing Promus Everolimus-Eluting Coronary Stent. The new stent being tested uses a platinum chromium alloy for more flexibility, thinner struts and a lower profile.

Boston Scientific reported a net loss for fiscal 2008 of $2 billion on revenue of $8 billion.