Shanghai, China，03 June , 2024 — Recently, AltaValve™, a transcatheter mitral valve replacement (TMVR) system developed by 4C Medical, has been granted two Breakthrough Device designations by the Food and Drug Administration (FDA). These designations specifically target treatment indications for moderate to severe or severe mitral regurgitation (MR) and moderate/severe MR with moderate/severe mitral annular calcification.
4C Medical specializes in developing innovative therapies for structural heart diseases, covering interventions for both mitral and tricuspid regurgitation. MicroPort® CardioFlow has previously made multiple rounds of investment in 4C Medical, becoming its largest shareholder and holding exclusive commercial rights for AltaValve™ in China.
The AltaValve™ system is the only fully retrievable low-profile TMVR system globally, poised to offer the world's first atrial-only fixation MR treatment solution upon its market release. Its innovative design maximally avoids the challenges of mitral annular anchoring present in existing TMVR technologies helping to protect cardiac structures during the procedure, reduce the risk of left ventricular outflow tract obstruction or damage, and enhance clinical outcomes.
The AltaValve™ system features a unique supra-annular valve and atrial fixation design, aligned parallel to the aorta, effectively minimizing impact on the left coronary anatomy and mitral valve structure to reduce the incidence of post-operative left ventricular outflow tract obstruction. Its flexible nitinol frame conforms closely to the left atrial anatomy, with a 24Fr valve frame providing possibilities for future left atrial interventions. The skirt made of PET material accelerates endothelialization, preventing paravalvular leaking. The device also incorporates a constant-size bovine pericardial valve, suitable for different left atrial implantation sizes, delivered through a 29Fr low-profile venous-transseptal approach, ensuring a safer and more convenient delivery pathway. Its full retrievability provides exceptional advantages for precise valve positioning and deployment.
The Breakthrough Device designations from the FDA reflect the unique achievements and leading position of the AltaValve™ system in the field of interventional MR treatment. An early feasibility study has shown positive results, and confirmatory clinical trials are expected to commence globally by the end of 2024 to support CE marking and FDA approval.