4C Medical's AltaValve System secures dual FDA Breakthrough Device Designations for mitral valve therapies.

4C Medical's AltaValve System secures dual FDA Breakthrough Device Designations, expediting patient access to advanced mitral valve therapies. The system, a transcatheter mitral valve replacement (TMVR) device, gained designations for treating moderate-to-severe or severe mitral regurgitation (MR) and MR with moderate/severe mitral annular calcification (MAC). The FDA's Breakthrough Device designation shortens the review process, potentially bringing the technology to patients faster.