4C Medical Technologies has discovered novel AltaValve System, an advanced transcatheter mitral valve replacement (TMVR) device. The FDA has awarded the AltaValve System Breakthrough Device designation for two therapeutic indications:
The AltaValve System presents a pioneering transcatheter therapeutic solution to address an unmet clinical need for patients who are not candidates for surgery or transcatheter edge-to-edge repair. Its atrial-only fixation design simplifies the complexities and variabilities of anchoring to the mitral annulus.
This innovative approach preserves critical cardiac structures, reducing the risk of left ventricular outflow tract obstruction or damage to the left ventricle. This advancement allows for the timely introduction of this essential technology to patients.
Mitral regurgitation (MR) occurs when blood flows backward through the mitral valve into the atrium during left ventricular contraction. If left untreated, MR can result in heart failure or death. The complexity of the mitral valve anatomy, along with common comorbidities in this patient population, limits the available medical therapies.
