4C Medical Technologies has secured dual breakthrough device designations from the US Food and Drug Administration (FDA) for its AltaValve system.
AltaValve System is a transcatheter mitral valve replacement (TMVR) device and the FDA’s designation marks a milestone in the treatment of mitral regurgitation (MR).
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The system received the FDA breakthrough device designations for two specific therapeutic indications.
They include the treatment of moderate-to-severe or severe MR, and moderate-to-severe or severe MR with moderate/severe mitral annular calcification (MAC).
MR is a condition where blood flows backwards through the mitral valve into the atrium with each contraction of the left ventricle. Untreated MR can lead to heart failure or death.
Due to the mitral valve anatomy complexity and the comorbidities often present in patients, there are limited medical therapies available.
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By GlobalData4C Medical founder and chief medical officer Dr Jeff Chambers said: “The AltaValve System offers a novel transcatheter therapeutic option to fulfil 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.”
AltaValve is claimed to have shown promising results in patients treated in 4C Medical’s early feasibility study.
The breakthrough device designation is expected to expedite the review process, potentially reducing the time until the technology becomes available to patients, pending FDA approval.
4C Medical is preparing to launch a global pivotal trial of the system later in 2024 for both indications.
This trial aims to support the CE mark and FDA approval.
4C Medical CEO and president Saravana Kumar said: “The dual breakthrough designation of the AltaValve System is an important milestone for the 4C Medical clinical programme, and we are excited to assess both indications in the upcoming AltaValve Pivotal trial.
“This advancement enables us the opportunity to bring this needed technology to our patients even sooner.”
As of now, the AltaValve System for TMVR is only available for investigational use and has not been approved for use outside of clinical trials.
In March 2022, 4C Medical secured $35.4m in a Series C Preferred Stock financing round.
