4C Medical Technologies has been granted breakthrough device designation by the US Food and Drug Administration (FDA) for the AltaValve system, a transcatheter mitral valve replacement (TMVR) device.
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 Ddevice designations for two therapeutic indications, which include 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.
“The AltaValve system offers a novel transcatheter therapeutic option to fulfil an unmet clinical need in patients who are unsuitable for surgery or transcatheter edge-to-edge repair. The atrial-only fixation of the technology is designed to minimise the complexities and variabilities associated with anchoring to the mitral annulus,” said Jeff Chambers, founder and chief medical officer of 4C Medical. “This differentiated approach preserves critical cardiac structures, reducing the risk of left ventricular outflow tract obstruction or damage to the left ventricle.”
Thus far, the AltaValve has achieved favourable 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 (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 dual Breakthrough Designation of the AltaValve System is an important milestone for the 4C Medical clinical program, and we are excited to assess both indications in the upcoming the AltaValve Pivotal trial,” said Saravana Kumar, CEO and President at 4C Medical. “This advancement enables us the opportunity to bring this needed technology to our patients even sooner.”
The AltaValve system for TMVR is available for investigational use only and it is not approved for use outside of clinical studies.
