A Medical Device Daily
Boston Scientific (Natick, Massachusetts) yesterday reported receiving FDA approval for its Liberté bare-metal coronary stent system. The company said it would launch the product in the U.S. immediately.
The Liberté stent serves as the platform for Boston Scientific’s next-generation paclitaxel-eluting stent system, Taxus Liberté. The company received the CE mark for the bare-metal Liberté stent system in December 2003 and said it plans to launch the Taxus Liberté system in Europe later this year. The Taxus Liberté system was launched in January in 18 other international markets.
The Liberté stent features Veriflex stent design, which the company calls “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.
In the U.S., Boston Sci said it has completed enrollment in its ATLAS clinical trial, a study designed to support FDA approval of the Taxus Liberté system. The company said it anticipates approval in mid-2006.
Paul LaViolette, Boston Scientific’s chief operating officer, said the Liberte, “featuring enhanced conformability and deliverability, is another step forward in helping clinicians treat coronary artery disease.”
Boston Scientific says its first paclitaxel-eluting coronary stent system, Taxus Express2, is “the worldwide leader in the coronary stent market.”