4C Medical Technologies, Inc. has announced that its AltaValve™ System, a transcatheter mitral valve replacement (TMVR) device, has received Breakthrough Device designation from the US Food and Drug Administration (FDA).

This designation signifies a key step forward in the regulatory journey of the AltaValve System. Among its benefits, Breakthrough Device designation expedites the review process, potentially shortening the time until this innovative technology becomes available to patients pending FDA approval.

The FDA has granted the AltaValve System Breakthrough Device designations for two therapeutic indications. Firstly, for the treatment of moderate-to-severe or severe mitral regurgitation (MR), and secondly, for the treatment of moderate-to-severe or severe MR with moderate/severe mitral annular calcification (MAC).

Mitral regurgitation, a condition where blood flows backward through the mitral valve and into the atrium with each contraction of the left ventricle, can lead to heart failure or death if left untreated. Dr. Jeff Chambers, Founder and Chief Medical Officer of 4C Medical, emphasized the significance of the AltaValve System in addressing this clinical need. He 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."

One of the distinguishing features of the AltaValve System is its atrial-only fixation, designed to minimize complexities and variabilities associated with anchoring to the mitral annulus. Dr. Chambers further highlighted that this approach aims to preserve critical cardiac structures, thereby reducing the risk of complications such as left ventricular outflow tract obstruction or damage.

Initial results from the Early Feasibility study conducted by 4C Medical have shown promising outcomes. Dr. Vlasis Ninios, an interventional cardiologist involved in the study, noted, "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."

Looking ahead, 4C Medical plans to initiate a global trial of the AltaValve System later in 2024 to support both CE mark and FDA approval for the designated therapeutic indications. Saravana Kumar, CEO and President at 4C Medical, expressed enthusiasm about the future prospects, stating, "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."

It's important to note that while the AltaValve System for TMVR is available for investigational use only, it holds promise as a potential game-changer in the field of structural heart disease treatment.