4C Medical Technologies has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for the AltaValve System, a transcatheter mitral valve replacement (TMVR) device. Among other benefits, Breakthrough Device designation expedites the review process, shortening the time until technology reaches patients if approved by the FDA.
Specifically, the FDA granted the AltaValve System Breakthrough Device designations for two therapeutic indications:
- Treatment of moderate-to-severe or severe mitral regurgitation (MR), and
- Treatment of moderate-to-severe or severe MR with moderate/severe mitral annular calcification (MAC).
MR occurs when blood flows backward through the mitral valve and into the atrium each time the left ventricle contracts. If left untreated, MR can lead to heart failure or death. Due to the complexity of the mitral valve anatomy and comorbidities typically present in this patient population, limited medical therapies are available to clinicians and their patients.
Thus far, the AltaValve has achieved favorable results in patients who were treated in the 4C Medical's Early Feasibility study.
"This data indicates that the AltaValve System is a promising option showing high procedural success and complete elimination of MR in most patients at 30 days," said Vlasis Ninios, M.D., interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece) and investigator in the study.
4C Medical anticipates commencing a global Pivotal trial of the AltaValve System later this year in 2024 for both indications to support CE mark and FDA approval.
The AltaValve System for TMVR is available for investigational use only and it is not approved for use outside of clinical studies.
