4C Medical's AltaValve System Receives Two FDA Breakthrough Device Designations, Speeding Up Access to Advanced Mitral Valve Therapies for Patients

Thursday, May 09, 2024

4C Medical Technologies, has recently been granted Breakthrough Device designation by the FDA for its AltaValve™ System, a cutting-edge transcatheter mitral valve replacement (TMVR) device.

This designation expedites the review process, potentially allowing for quicker patient access upon FDA approval.

The AltaValve System has been designated as a Breakthrough Device for two significant therapeutic indications:

  1. Treatment of moderate-to-severe or severe mitral regurgitation (MR).
  2. Treatment of moderate-to-severe or severe MR with moderate/severe mitral annular calcification (MAC).

MR occurs when blood flows backward through the mitral valve into the atrium during contractions of the left ventricle, potentially leading to severe complications if left untreated.

Current medical therapies for MR are limited due to the complex anatomy of the mitral valve and associated comorbidities in patients.

This device offers a novel transcatheter therapeutic option for patients who are not suitable candidates for surgery or transcatheter edge-to-edge repair.

Its atrial-only fixation aims to simplify the procedure by minimizing complexities associated with anchoring to the mitral annulus, thereby reducing risks and preserving critical cardiac structures."

Initial results from 4C Medical's Early Feasibility study (NCT03997305) have shown promising outcomes.The data indicates high procedural success and complete elimination of MR in most patients at the 30-day mark."

4C Medical plans to commence a global Pivotal trial later in 2024 for both indications to support CE mark and FDA approval.

The dual Breakthrough Designation marks a significant step forward for our clinical program, bringing us closer to delivering this crucial technology to patients.

It's important to note that the AltaValve System is currently for investigational use only and has not been approved for use outside of clinical studies.


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