Friday, October 10, 2008

Boston Scientific stent gets FDA approval

By Mass High Tech Staff

Natick-based Boston Scientific Corp. plans to begin selling its Taxus Liberte Paclitaxel-Eluting Coronary Stent System in the U.S., following today’s announced approval from the U.S. Food and Drug Administration. The stent has been available in the European and other global markets since 2005.

The medical giant is currently introducing its FDA-approved Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System in the U.S.

The stent is designed with thinner struts than the company’s previous stents, better deliverability and uniform strut distribution, Boston Scientific chief medical officer Donald Baim said.

The Taxus Liberte stent, as well as the Taxus Express2 stent, have both passed clinical trials and added data from more than 35,000 patients to their studies. A total of 4.6 million Taxus stents are being used around the world, Boston Scientific officials report.

News of the FDA approval of the Liberte stent comes just a week after the dust has settled from the lengthy patent infringement lawsuit instigated by rival Johnson & Johnson Co. The legal disputes ended in court on Oct. 1 with an order for Boston Scientific to pay some $703 million in patent damages to Johnson & Johnson over a coronary stent dispute. An appeal from Boston Scientific was rejected by the U.S. Supreme Court this week.

Boston Scientific (NYSE: BSX) reported a 2007 net loss of $495 million on revenue of $8.4 billion.