ABBOTT PARK, Illinois, February 1 /PRNewswire/ -- Abbott (NYSE: ABT - News) today announced that it has received reimbursement approval in France for its XIENCE(TM) V Everolimus Eluting Coronary Stent System, the first drug eluting stent to demonstrate clinical superiority over another drug eluting stent in a randomized clinical trial.
Recognizing superior clinical results for XIENCE V compared to the TAXUS® paclitaxel-eluting coronary stent system in the SPIRIT II and III randomized clinical trials, the French Health Authority (Haute Autorite de Sante) granted XIENCE V an ASA Level IV medical benefit rating (Amelioration du Service Attendu). This distinction recognizes an improved medical benefit for XIENCE V compared to TAXUS. Abbott’s XIENCE V drug eluting stent will become available to all public and private hospitals throughout France in February.
“By awarding XIENCE V reimbursement and a higher medical benefit rating than previous generation drug eluting stent technology, the French Health Authority has recognized that XIENCE V represents an important advancement in treatment,” said John M. Capek, Ph.D., executive vice president, Medical Devices, Abbott. “Abbott looks forward to introducing XIENCE V as a new standard of care in the treatment of coronary artery disease to physicians and patients in France.”
The French Health Authority based its reimbursement evaluation for Abbott’s XIENCE V drug eluting stent on the results from three randomized clinical trials: SPIRIT FIRST, SPIRIT II and SPIRIT III. In this SPIRIT family of trials, XIENCE V demonstrated:
-- Superiority for XIENCE V compared to TAXUS in the primary endpoint of in-segment late loss at eight months in the SPIRIT III clinical trial, with a statistically significant 50 percent reduction in late loss for XIENCE V. In-segment late loss is a measure of vessel renarrowing.
-- An observed 43 percent reduction in major adverse cardiac events (MACE) compared to TAXUS at one year in SPIRIT III. MACE is an important clinical measure of safety and efficacy outcomes for patients, and is defined as cardiac death, heart attack (myocardial infarction or MI), or ischemia-driven target lesion revascularization (TLR associated with symptoms or documented lack of blood supply).
-- Non-inferiority to TAXUS with an observed 23 percent reduction in Target Vessel Failure (TVF) for XIENCE V compared to TAXUS in the SPIRIT III clinical trial at one year. Target Vessel Failure is a measure of re-treatment anywhere within the target vessel and includes cardiac death or heart attack.
-- Superiority for XIENCE V compared to TAXUS in the primary endpoint of angiographic in-stent late loss in the SPIRIT II clinical trial at six months. In-stent late loss is a measure of vessel renarrowing within the margins of the stent.
“The development and availability of new and improved therapies to treat heart disease in France is critical to improving public health,” said Marie-Claude Morice, M.D., Institut Cardiologique Paris Sud, Massy, France. “The availability of the XIENCE V drug eluting stent in France is in the best interests of our physicians and patients.”
XIENCE V was launched in Europe and other international markets in late 2006. XIENCE V is an investigational device in the United States and Japan, and is currently under review for approval by the U.S. Food and Drug Administration.
Abbott also supplies a private-label version of XIENCE V to Boston Scientific called the PROMUS(TM) Everolimus-Eluting Coronary Stent System. PROMUS is designed, studied and manufactured by Abbott and supplied as part of a distribution agreement between the two companies.
About Abbott Vascular
Abbott Vascular, a division of Abbott, is one of the world’s leading vascular care businesses. Abbott Vascular is uniquely focused on advancing the treatment of vascular disease and improving patient care by combining the latest medical device innovations with world-class pharmaceuticals, investing in research and development, and advancing medicine through training and education. Headquartered in Northern California, Abbott Vascular offers a comprehensive portfolio of vessel closure, endovascular and coronary products that are recognized internationally for their safety and effectiveness in treating patients with vascular disease.
About Abbott
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott’s news releases and other information are available on the company’s Web site at http://www.abbott.com.
Web site: http://www.abbott.com
Source: Abbott
