4C Medical Technologies, a company specializing in minimally invasive therapies for structural heart disease, has earned Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its AltaValve™ System.
This designation aims to accelerate the review process, potentially bringing the technology to patients more quickly upon FDA approval.
The AltaValve System received Breakthrough Device designation for two therapeutic indications:
Mitral regurgitation, a condition where blood flows backward through the mitral valve into the atrium with each contraction of the left ventricle, can lead to heart failure or death if untreated.
The complex anatomy of the mitral valve and common comorbidities in these patients often limit treatment options.
The System provides an innovative transcatheter solution for patients unsuitable for surgery or transcatheter edge-to-edge repair. Its atrial-only fixation aims to simplify the procedure and reduce risks, preserving critical cardiac structures and lowering the chances of left ventricular outflow tract obstruction or left ventricular damage.
4C Medical plans to initiate a global pivotal trial for the AltaValve System later in 2024 to support both CE mark and FDA approval.
The dual Breakthrough Designation is a significant milestone for the clinical program, paving the way for a thorough evaluation of both indications in the upcoming pivotal trial and bringing essential technology to patients more swiftly.
Source: https://www.prnewswire.com/news-releases/4c-medicals-altavalve-system-secures-dual-fda-breakthrough-device-designations-expediting-patient-access-to-advanced-mitral-valve-therapies-302139191.html
