Xintong Medical-B (02160) issued an announcement. AltaValve's transcatheter mitral valve replacement medical device is close...
Zhitong Finance App News, Xintong Medical-B (02160) announced that AltaValve's transcatheter mitral valve replacement medical device was recently awarded the title of breakthrough device by the US Food and Drug Administration. AltaValve is a TMVR (transcatheter mitral valve replacement) product jointly developed by the Group and partner 4c Medical Technologies, Inc. to treat (a) moderate to severe or severe mitral valve reflux and (b) moderate to severe MR with moderate/severe mitral valve ring calcification.
AltaValve provides innovative transcatheter treatment options to meet the unmet clinical needs of patients who are unsuitable for surgery or transcatheter edge repair. This atrial-only fixation technique aims to minimize the complexity and variability associated with anchored mitral annulus. This differentiated approach preserves key cardiac structures and can reduce the risk of left ventricular outflow obstruction or left ventricular damage.
The FDA's breakthrough device title recognises AltaValve as a device that should be quickly reviewed to provide treatment to patients as early as possible. This title is given to devices that have the potential to provide more effective treatments or to diagnose fatal or irreversible diseases. 4C Medical has obtained positive results in AltaValve's early feasibility studies and is expected to conduct confirmatory clinical trials globally by the end of 2024 to support its CE marking and FDA approval.