HeartTech Medical-B Announces AltaValve™ Granted FDA Breakthrough Device Designation

　　MicroPort CardioFlow-B(02160) announces that AltaValve™, a transcatheter mitral valve replacement (TMVR) medical device, has recently been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA). AltaValve™ is a TMVR product jointly developed by the group and its partner, 4C Medical Technologies, Inc., used for treating (a) moderate to severe or severe mitral regurgitation (MR) and (b) moderate to severe or severe MR associated with moderate/severe mitral annular calcification.

AltaValve™ offers an innovative transcatheter treatment solution to meet the unmet clinical needs of patients who are not suitable for surgery or transcatheter edge-to-edge repair. This atrial-only fixation technology aims to minimize the complexity and variability associated with anchoring to the mitral valve annulus. This differentiated approach preserves critical cardiac structures, reducing the risk of left ventricular outflow tract obstruction or left ventricular injury.

Editor: Lu Yu-jun