4C Medical’s AltaValve System Receives FDA Breakthrough Device Designations

May 8, 2024—4C Medical Technologies, Inc. has been granted Breakthrough Device designation by the FDA for the AltaValve system, a transcatheter mitral valve replacement (TMVR) device for two indications: (1) the treatment of moderate-to-severe or severe mitral regurgitation (MR) and (2) treatment of moderate-to-severe or severe MR with moderate/severe mitral annular calcification.

The company anticipates commencing a global pivotal trial of the AltaValve system in 2024 for both indications to support CE Mark and FDA approval.

Additionally, 4C Medical stated the device has achieved favorable results in patients who were treated in the AltaValve Early Feasibility Study.

“These data indicate that the AltaValve system is a promising option showing high procedural success and complete elimination of MR in most patients at 30 days,” commented Study Investigator Vlasis Ninios, MD, in the company’s press release. Dr. Ninios is an interventional cardiologist at Interbalkan Medical Center in Thessaloniki, Greece.

The AltaValve system for TMVR is available for investigational use only and it is not approved for use outside of clinical studies, advised 4C Medical.

Jeff Chambers, MD, who is Founder and Chief Medical Officer of 4C Medical, stated, “The AltaValve system offers a novel transcatheter therapeutic option to fulfill 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 minimize the complexities and variabilities associated with anchoring to the mitral annulus. This differentiated approach preserves critical cardiac structures, reducing the risk of left ventricular outflow tract obstruction or damage to the left ventricle.”