Sam Brusco, Associate Editor05.08.24
4C Medical Technologies was awarded Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its AltaValve transcatheter mitral valve replacement (TMVR) device.
AltaValve was specifically granted breakthrough status for two indications: Treating moderate-to-severe mitral regurgitation (MR) and moderate-to-severe- or severe MR with moderate/severe mitral annular calcification (MAC).
4C Medical’s TMVR differentiates from other MR replacement devices with an atrial-only fixation. It preserves the native mitral valve and left ventricle, minimizing challenges associated with traditional TMVR replacement technologies. These rely on placement and fixation in the native mitral annulus and left ventricle.
The atrial-only fixation of the technology is designed to minimize the complexities and variabilities associated with anchoring to the mitral annulus," said Dr. Jeff Chambers, founder and chief medical officer of 4C Medical. "This differentiated approach preserves critical cardiac structures, reducing the risk of left ventricular outflow tract obstruction or damage to the left ventricle."
The company achieved favorable results for patients treated in its early feasibility study. AltaValve was shown to be a promising option with high procedure success and MR elimination in most patients at 30 days, according to Vlasis Ninios, M.D., interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece) and an investigator in the study.
"The dual Breakthrough Designation of the AltaValve System is an important milestone for the 4C Medical clinical program, and we are excited to assess both indications in the upcoming the AltaValve Pivotal trial," said 4C Medical CEO Saravana Kumar. "This advancement enables us the opportunity to bring this needed technology to our patients even sooner."
AltaValve was specifically granted breakthrough status for two indications: Treating moderate-to-severe mitral regurgitation (MR) and moderate-to-severe- or severe MR with moderate/severe mitral annular calcification (MAC).
4C Medical’s TMVR differentiates from other MR replacement devices with an atrial-only fixation. It preserves the native mitral valve and left ventricle, minimizing challenges associated with traditional TMVR replacement technologies. These rely on placement and fixation in the native mitral annulus and left ventricle.
The atrial-only fixation of the technology is designed to minimize the complexities and variabilities associated with anchoring to the mitral annulus," said Dr. Jeff Chambers, founder and chief medical officer of 4C Medical. "This differentiated approach preserves critical cardiac structures, reducing the risk of left ventricular outflow tract obstruction or damage to the left ventricle."
The company achieved favorable results for patients treated in its early feasibility study. AltaValve was shown to be a promising option with high procedure success and MR elimination in most patients at 30 days, according to Vlasis Ninios, M.D., interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece) and an investigator in the study.
"The dual Breakthrough Designation of the AltaValve System is an important milestone for the 4C Medical clinical program, and we are excited to assess both indications in the upcoming the AltaValve Pivotal trial," said 4C Medical CEO Saravana Kumar. "This advancement enables us the opportunity to bring this needed technology to our patients even sooner."