June 1, 2007 — Abbott announced it has completed its application to the U.S. Food and Drug Administration (FDA) to seek market approval for its XIENCE V Everolimus Eluting Coronary Stent System to treat coronary artery disease, with the submission of the final module of its Pre-Market Approval (PMA) application.
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 the TAXUS Paclitaxel-Eluting Coronary Stent System in the primary endpoint of reducing vessel re-narrowing (angiographic late loss).
"This is the first-ever PMA submission to include head-to-head clinical trial results that demonstrated superiority of one drug-eluting stent over another in the primary endpoint," said John M. Capek, Ph.D., senior vice president, Abbott Vascular. "With the filing of our third and final PMA module, we have submitted all the pre-agreed data necessary to complete our application for XIENCE V approval in the United States. We look forward to bringing XIENCE V to U.S. physicians and patients."
Abbott's PMA submission for the XIENCE V Everolimus Eluting Coronary Stent System includes data from the following clinical trials:
-- SPIRIT FIRST, a randomized trial comparing the XIENCE V Everolimus
Eluting Coronary Stent System with the MULTI-LINK VISION® metallic
stent system. SPIRIT FIRST met its primary endpoint and demonstrated
no stent thrombosis out to three years.
-- SPIRIT II, a randomized clinical trial evaluating XIENCE V versus TAXUS in Europe and Asia Pacific. SPIRIT II met its primary endpoint and demonstrated the superiority of XIENCE V to TAXUS on in-stent late loss at six months. In-stent late loss is a measure of vessel re-narrowing along the length of the stent.
-- SPIRIT III, a large-scale, randomized pivotal clinical trial comparing XIENCE V to TAXUS in the United States, with additional registry arms in the U. S. and Japan. SPIRIT III met its primary endpoint and demonstrated the superiority of XIENCE V to TAXUS on in-segment late loss at eight months. In-segment late loss is a measure of vessel re-narrowing along the length of the stent, plus 5 mm beyond the ends of the stent.
"As history unfolds in drug-eluting stent treatment, it has become apparent that there is a critical need for new, next-generation platforms with the potential to improve patient care," said Gregg W. Stone, M.D., of Columbia University Medical Center and the Cardiovascular Research Foundation, New York, and principal investigator in the SPIRIT II and III trials. "Abbott's XIENCE V stent system was designed with the intent of improving upon existing technology, and holds promise for patients as a next-generation treatment in coronary care."
Abbott expects to launch XIENCE V in the United States in the first half of 2008.
The final PMA module that Abbott submitted also requests FDA approval for the PROMUS(TM) Everolimus Eluting Coronary Stent System, which will be distributed by Boston Scientific and is a private-labeled version of the XIENCE V Everolimus Eluting Coronary Stent System. XIENCE V is designed, studied and manufactured by Abbott.
For more information visit: www.abbott.com