Edwards Sapien Transcatheter Heart Valve and Accessories

Approval order statement

APPROVAL FOR EDWARDS SAPIEN¿ TRANSCATHETER HEART VALVE MODEL 9000TFX, SIZES 23MM AND 26MM, AND TRANSAPICAL AND TRANSFEMORAL ACCESSORIES LISTED ABOVE. THIS DEVICE IS INDICATED FOR THE FOLLOWING:TRANSAPICAL - THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23 MM AND 26 MM, IS INDICATED FOR TRANSAPICAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVESTENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION >= 20% WHO HAVE BEEN EXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TO BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >= 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >=15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT. THE ASCENDRA BALLOON CATHETER IS INDICATED FOR THE TRANSAPICAL DELIVERY OF THE EDWARDS SAPIEN TRANSCATHETER HEART VALVE. TRANSFEMORALTHE EDWARDS SAPIEN TRANSCATHETER HEART VALVE, MODEL 9000TFX, SIZES 23 MM AND 26 MM, ISINDICATED FOR TRANSFEMORAL DELIVERY IN PATIENTS WITH SEVERE SYMPTOMATIC CALCIFIED NATIVE AORTIC VALVESTENOSIS WITHOUT SEVERE AORTIC INSUFFICIENCY AND WITH EJECTION FRACTION >20% WHO HAVE BEENEXAMINED BY A HEART TEAM INCLUDING AN EXPERIENCED CARDIAC SURGEON AND A CARDIOLOGIST AND FOUND TOEITHER BE: 1) INOPERABLE AND IN WHOM EXISTING CO-MORBIDITIES WOULD NOT PRECLUDE THE EXPECTEDBENEFIT FROM CORRECTION OF THE AORTIC STENOSIS; OR 2) BE OPERATIVE CANDIDATES FOR AORTIC VALVE REPLACEMENT BUT WHO HAVE A SOCIETY OF THORACIC SURGEONS PREDICTED OPERATIVE RISK SCORE > 8% OR ARE JUDGED BY THE HEART TEAM TO BE AT A >15% RISK OF MORTALITY FOR SURGICAL AORTIC VALVE REPLACEMENT.THE RETROFLEX 3 DELIVERY SYSTEM IS INDICATED FOR THE TRANSFEMORAL DELIVERY OF THE EDWARDSSAPIEN TRANSCATHETER HEART VALVE.