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FDA grants 4C Medical’s new TMVR device Breakthrough Device Designation

“The AltaValve System offers a novel transcatheter treatment option to address unmet clinical needs in patients who are not candidates for surgery or edge-to-edge transcatheter repair,” said Jeff Chambers, M.D., founder and chief medical officer of 4C Medical. statement. “Vestibular-only anchorage technology is intended to minimize the complexity and variability associated with mitral annulus anchorage. This differentiated approach preserves critical heart structures, reducing the risk of left ventricular outflow tract obstruction or damage.”

“The dual breakthrough designation for the AltaValve system is an important milestone for 4C Medical’s clinical program, and we are pleased to evaluate both indications in the upcoming AltaValve Pivotal study,” added Saravana Kumar, CEO and president of 4C Medical. “With this advancement, we have the opportunity to make the technology they need available to our patients even faster.”

This new TMVR device is still in development and has not been approved by the FDA for use outside of experimental studies.

4C Medical plans to launch a larger, global study by the end of the year in an effort to obtain FDA and CE Mark approval.