Boston Scientific Announces FDA Approval of Libert Stent System

Boston Scientific has received FDA approval for its Libert bare-metal coronary stent system and plans to launch the product immediately in the U.S.

The Libert stent serves as the platform for Boston Scientific's next-generation paclitaxel-eluting stent system, Taxus Libert. Boston Scientific received the CE Mark for the bare-metal Libert stent system in December 2003 and plans to launch the Taxus Libert system in Europe later this year.

The Libert stent features Veriflex stent design, a highly flexible cell design with thin struts for enhanced deliverability in challenging anatomy as well as the TrakTip catheter tip used with the Maverick2 delivery catheter, which provides improved lesion crossability. The company has completed enrollment in its ATLAS clinical trial, a pivotal study designed to support FDA approval of the Taxus Libert stent system, and it anticipates FDA approval in mid-2006.