February 1, 2008 - Abbott has received reimbursement approval in France for its XIENCE 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, according to the manufacturer.
The French Health Authority (Haute Autorite de Sante) granted XIENCE V an ASA Level IV medical benefit rating (Amelioration du Service Attendu). 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, PhD, 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 reportedly 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.
“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 is an investigational device in the United States and Japan, and is currently under review for approval by the FDA.
For more information: www.abbott.com