Newsletter summary

The AltaValve transcatheter mitral valve replacement medical instrument developed by Xintong Medical treatment-B (02160) has been awarded the title of groundbreaking equipment by FDA in the United States.3wtreelA global confirmatory clinical trial is expected by the end of 2024.

Text of news flash

[the AltaValve medical device of Xintong Medical-B (02160) was certified by FDA breakthrough equipment]

Xintong Medical-B (02160) announced that AltaValve transcatheter mitral valve replacement medical devices have won the title of breakthrough equipment awarded by the Food and Drug Administration (FDA). This indicates that its products are expected to provide patients with advanced treatment options in the near future.

AltaValve is a combination of Xintong Healthcare-B and 4C Medical Technologies.3wtreel, Inc3wtreel. The TMVR (transcatheter mitral valve replacement) product is jointly developed to treat severe mitral regurgitation patients with moderate to severe mitral annulus calcification or moderate severe mitral annular calcification.

The innovation of this treatment scheme is to provide for patients who are not suitable for open surgery or edge-to-edge repair.3wtreelThere is an alternative. AltaValve uses atrial fixation techniques to reduce the complexity and variability associated with anchored mitral annulus while preserving key cardiac structures and reducing the risk of left ventricular outflow tract obstruction or left ventricular injury.

The breakthrough equipment identification of FDA shows that AltaValve has a significant advantage in therapeutic potential and is expected to provide more effective treatment or diagnose fatal or irreversible diseases than traditional treatments. According to 4C Medical, AltaValve has shown positive results in early feasibility studies and is expected to launch confirmatory clinical trials worldwide by the end of 2024 to promote its CE tagging and US FDA approval process.