FDA Approves Boston Scientific's TAXUS Liberte Atom Coronary Stent

 

May 28, 2009
TAXUS Liberte Atom

May 28, 2009 - Boston Scientific Corp. said yesterday it received FDA clearance to market its TAXUS Liberte Atom Paclitaxel-Eluting Coronary Stent System, a next-generation drug-eluting stent (DES) specifically designed for treating small coronary vessels.

It was approved for use in vessels as small as 2.25 mm in diameter and joins the TAXUS Express Atom Stent as the only DES approved for small vessel use in the U.S. The company plans to begin a full U.S. launch of TAXUS Liberte Atom in June.

The TAXUS Liberte Atom features design improvements over the company's first-generation TAXUS Express Atom, including thinner struts to allow better stent deliverability and conformability, as well as uniform stent geometry for consistent lesion coverage and drug distribution, the company said.

"The rapid adoption of the TAXUS Express Atom Stent has confirmed the need for this type of stenting option in the treatment of small-vessel coronary artery disease," said Mark Turco, M.D., FACC, FSCAI, director of the Center for Cardiac and Vascular Research at Washington Adventist Hospital, Takoma Park, Md. “The TAXUS Liberte Atom Stent provides clear design and deliverability advantages. Additionally, in the TAXUS Atlas Small Vessel clinical trial, the TAXUS Liberte Atom Stent yielded a two-year target lesion revascularization rate that was 60 percent less than the TAXUS Express Atom Stent. I am pleased to be able to offer this option to my patients."

Data from numerous clinical studies have shown that an estimated 10 percent of patients undergoing percutaneous coronary interventions have small vessels.
Boston Scientific offers the industry's widest range of coronary stent sizes. The Company expects to expand its stent portfolio later this year with the first 38 mm long DES, the TAXUS Liberte Long Stent, which is currently under review with the FDA.

For more information: www.bostonscientific.com, www.angiotech.com