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4C Medical wins dual FDA breakthrough nods for mitral valve replacement device

4C Medical Technologies announced today that 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).

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.

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