4C Medical Technologies has received two breakthrough device designations from the US Food and Drug Administration (FDA) for the AltaValve System.
The AltaValve System is a transcatheter mitral valve replacement (TMVR) device.
The FDA has granted breakthrough status for the device in the treatment of moderate-to-severe or severe mitral regurgitation (MR). The device has also been given the same designation in the treatment of moderate-to-severe or severe MR with moderate/severe mitral annular calcification (MAC).
4C Medical Technologies said that the AltaValve System will support MR treatment with its unique atrial fixation.
The device is designed to address the limitations of conventional TMVR technologies by preserving the native mitral valve and left ventricle.
The breakthrough device designations are expected to accelerate the review process, reducing the time until the AltaValve System reaches patients after receiving the FDA’s approval.
4C Medical Technologies founder and chief medical officer Jeff Chambers said: “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.
“The atrial-only fixation of the technology is designed to minimise the complexities and variabilities associated with anchoring to the mitral annulus.
“This differentiated approach preserves critical cardiac structures, reducing the risk of left ventricular outflow tract obstruction or damage to the left ventricle.”
According to 4C Medical Technologies, AltaValve has shown promising results in an early feasibility study.
The medical device company plans to start a global pivotal trial for the system later this year for both indications to obtain the CE mark and FDA approval.
Study investigator and Interbalkan Medical Center interventional cardiologist Vlasis Ninios said: “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.”
The AltaValve System is currently limited to investigational use and has not received approval for use outside clinical trials.
4C Medical Technologies develops medical devices for structural heart diseases. Initially targeting MR therapy, the company plans to focus on tricuspid regurgitation therapy.
