Edwards Sapien XT Transcatheter Heart Valve and Accessories

Approval order statement

APPROVAL FOR THE SAPIEN XT TRANSCATHETER HEART VALVE (THV), MODEL 9300TFX, AND ACCESSORIES. THIS DEVICE IS INDICATED FOR RELIEF OF AORTIC STENOSIS IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO SEVERE NATIVE CALCIFIC AORTIC STENOSIS (AORTIC VALVE AREA <=1.0 CM2 OR AORTIC VALVE AREA INDEX <=0.6 CM2/M2, A MEAN AORTIC VALVE GRADIENT OF >= 40 MMHG, OR A PEAK AORTIC-JET VELOCITY OF >= 4.0 M/S), AND WITH NATIVE ANATOMY APPROPRIATE FOR THE 23, 26, OR 29 MM VALVE SYSTEM, WHO ARE JUDGED BY A HEART TEAM, INCLUDING A CARDIAC SURGEON, TO BE AT HIGH OR GREATER RISK FOR OPEN SURGICAL THERAPY (I.E., SOCIETY OF THORACIC SURGEONS OPERATIVE RISK SCORE >=8% OR AT A >=15% RISK OF MORTALITY AT 30 DAYS).