Abbott Laboratories (ABT)

[THE LURKER]

Abbott Submits XIENCE V for U.S. FDA Approval




With the first-ever Pre-Market Approval (PMA) submission to include head-to-head clinical trial results demonstrating superiority of one drug-eluting stent over another, Abbott completed its application to the U.S. Food and Drug Administration seeking U.S. market approval for its XIENCE V Everolimus Eluting Coronary Stent System to treat coronary artery disease.

Abbott’s PMA submission includes safety and efficacy data from the XIENCE V SPIRIT family of clinical trials, which demonstrated superior results for XIENCE V over Boston Scientific’s TAXUS® drug-eluting coronary stent system in the primary endpoint of reducing vessel re-narrowing.

XIENCE V was launched in Europe and Asia Pacific in 2006 and is currently an investigational device in the United States and Japan. Abbott expects to launch XIENCE V in the United States in the first half of 2008