4C Medical’s ATLAS Pivotal Trial of AltaValve TMVR System Commences Enrollment

October 14, 2024—4C Medical Technologies, Inc. recently announced it has commenced enrollment in the ATLAS pivotal trial in Europe and United States.

According to the company, ATLAS is designed to assess the safety and efficacy performance of its AltaValve, a transseptal left atrial system, in treating patients with moderate-to-severe or severe mitral regurgitation who are unsuitable for surgery or transcatheter edge-to-edge repair.

The company advised that the trial is designed with two separate nonrandomized cohorts:

• Moderate/severe mitral annular calcification (MAC) cohort
• Primary cohort will include patients with no or mild MAC

Ron Waksman, MD, an interventional cardiologist at Medstar Washington Hospital Center in Washington, DC, is the steering committee chair for the ATLAS trial.

“The AltaValve system is the first atrial fixation transcatheter mitral valve replacement (TMVR) device that is designed to minimize challenges of the subvalvular TMVRs, especially screen failures associated with the risk of left ventricular outflow tract obstruction, damage to the left ventricle, and MAC,” commented Dr. Waksman in the company’s press release.

Paul Sorajja, MD, and Yoshi Kaneko, MD, are the trial's coprincipal investigators in the United States. In Europe, the coprincipal investigators are Vlasis Ninios, MD, and Lenard Conradi, MD.

“We are excited to have successfully enrolled the first United States patients in the ATLAS trial,” stated Dr. Sorajja in the press release. “I am particularly excited as the AltaValve system is designed to offer the broadest applicability for a wide range of pathologies. It is an intuitive and predictable procedure with a repositionable implant that is very much needed for the treatment of patients worldwide.”

Dr. Sorajj is an interventional cardiologist at Minneapolis Heart Institute in Minneapolis, Minnesota. Dr. Kaneko is a cardiothoracic surgeon at Barnes-Jewish Hospital in St. Louis, Missouri. Dr. Ninios is an interventional cardiologist at Interbalkan Medical Center in Thessaloniki, Greece. Dr. Conradi is a cardiothoracic surgeon at University Hospital Cologne in Cologne, Germany.