Boston Scientific gets FDA approval for new stent

Boston Scientific Corp., the Natick medical device maker, today announced it has received approval from the Food and Drug Administration to market its second-generation TAXUS Liberte Paclitaxel-Eluting Coronary Stent System in the United States.

The company said it plans to launch the TAXUS Liberte stent early next month in the United States, following completion of the introduction of its TAXUS(R) Expresss2 Atom Paclitaxel-Eluting Coronary Stent System, which was approved by the FDA last month.

The TAXUS Liberte stent was launched in Europe and other international markets in 2005, Boston Scientific said.

But the stent was "delayed in the US by a sweeping warning letter issued by the FDA in 2006 over corporate quality issues," the AP noted in its story on the announcement today.

Stents are wire mesh tubes used to keep open arteries that have been cleared during a medical procedure. Some stents are also coated to release, or elute, drugs that aim to promote healing.

"The TAXUS Liberte stent represents our latest advance in drug-eluting stent technology," Donald Baim, chief medical and scientific officer of Boston Scientific, said in a statement. "This device has substantially thinner struts and a more flexible cell geometry for improved deliverability, as well as uniform strut distribution designed specifically for drug elution."

To read previous some stories about Boston Scientific and the Taxus stent, please click here.
(By Chris Reidy, Globe staff)