MINNEAPOLIS , Oct. 8, 2024 /PRNewswire/ -- 4C Medical Technologies, Inc. ("4C Medical"), a medical device company dedicated to advancing minimally invasive therapies for structural heart disease, has commenced enrollment in the ATLAS ( A T ransseptal L eft A trial S ystem for Treatment of Mitral Regurgitation) trial in Europe and United States .
ATLAS is a pivotal trial that is designed to assess the safety and efficacy performance of its AltaValve TM System in treating patients with moderate-to-severe or severe mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair (NCT06465745). The trial is designed with two separate non-randomized cohorts.: a) Moderate/severe mitral annular calcification (MAC) Cohort, and b) Primary Cohort that will include patients with no or mild MAC.
"The AltaValve System is the first atrial fixation transcatheter mitral valve replacement (TMVR) device that is designed to minimize challenges of the sub-valvular TMVRs, especially screen failures associated with risk of the risk of left ventricular outflow tract obstruction, damage to the left ventricle and MAC," said Ron Waksman , M.D., interventional cardiologist at Medstar Washington Hospital Center ( Washington, DC ) and the Steering Committee Chair for the ATLAS trial.
"We are excited to have successfully enrolled the first US patients in the ATLAS trial. I am particularly excited as the AltaValve System is designed to offer the broadest applicability for wide .