FDAnews Device Daily Bulletin

ABIOMED ANNOUNCES FRENCH REGULATORY APPROVAL OF THE AB5000 CIRCULATORY SUPPORT SYSTEM

May 24, 2006
A A

ABIOMED, Inc. May 22 announced that the French regulatory agency for medical devices, the Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS) has granted approval of the AB5000 Circulatory Support System. France represents one of the largest medical device markets in Europe. All of ABIOMED's Circulatory Support Systems including the IMPELLA products are now available in France, providing French patients in acute heart failure with access to life-saving circulatory support. In addition, ABIOMED announced plans to open an office in Paris to provide French customers with direct customer service, and sales and clinical expertise as they incorporate Ventricular Assist Device (VAD) Recovery Programs into standard clinical practice. Abiomed (http://www.abiomed.com/news/ab5k_france_approval.cfm)