4C Medical Technologies announced the FDA granted breakthrough device designation for its AltaValve system. The company received designations for two therapeutic indications for the transcatheter mitral valve replacement (TMVR) device. It can look at the valve for the treatment of moderate-to-severe or severe mitral regurgitation (MR). The company can also evaluate AltaValve in moderate-to-severe or severe MR with moderate/severe mitral annular calcification (MAC).
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Minneapolis-based 4C hopes for its technology to address MR, which can lead to heart failure or death if untreated. Due to the complexity of the valve’s anatomy and comorbidities, limited medical therapies currently exist for MR. It could enter a market currently led by the Abbott MitraClip transcatheter mitral valve repair system.
Dr. Jeff Chambers, founder and chief medical officer of 4C, says AltaValve offers a novel option to fulfill an unmet need. It could help patients who prove unsuitable for surgery or transcatheter edge-to-edge repair (TEER). Atrial-only fixation can minimize the complexities and variables associated with anchoring to the mitral annulus, he said. This preserves critical cardiac structures.
To date, 4C reports positive results from its early feasibility study. Investigator Dr. Vlasis Ninios called it a promising option with high procedural success and complete elimination of MR in most patients at 30 days.
4C expects to begin a global pivotal trial of the AltaValve system later this year with hopes 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.”
