Minnesota, USA, 23 October 2024 - Recently, the AltaValve™ system, a transcatheter mitral valve replacement (TMVR) device developed by MicroPort^® CardioFlow’s strategic partner 4C Medical, initiated a pivotal clinical trial in Europe and the United States. The trial, named ATLAS (A Transseptal Left Atrial System for Treatment of Mitral Regurgitation), aims to evaluate the safety and efficacy of the AltaValve™ 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 result will support its CE marking and FDA approval.

The AltaValve™ system is currently the world's only fully retrievable and low-profile TMVR system, poised to offer the world's first atrial-only fixation MR treatment solution upon its market release. Its innovative design effectively addresses the mitral annular anchoring challenges present in current TMVR technologies, protecting the patient’s heart structures during the procedure and minimizing the risk of left ventricular outflow tract obstruction or damage, resulting in safer and more superior clinical outcomes. In addition, the system employs a one-step release and positioning mechanism, simplifying the procedure and significantly shortening the learning curve for clinicians. Earlier this year, the AltaValve™ system was granted two Breakthrough Device designations by FDA, covering the indications for “moderate to severe or severe MR” and “moderate to severe or severe MR with moderate/severe mitral annular calcification.”

The ATLAS trial includes two independent, non-randomized cohorts: a) Cohort with moderate/severe mitral annular calcification (MAC) ; b) Primary cohort that includes patients with no MAC or mild MAC. 

"The AltaValve™ system is the first atrial fixation TMVR device that is designed to minimize challenges of the sub-valvular TMVRs, especially screen failures associated with 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 range of pathologies," said Paul Sorajja, M.D., interventional cardiologist at Minneapolis Heart Institute (Minneapolis, MN) and Co-Principal Investigator (PI) of the trial. "It is an intuitive and predictable procedure with a repositionable implant that is very much needed for the treatment of patients worldwide." 

Dr. Yoshi Kaneko, cardiothoracic surgeon at Barnes-Jewish Hospital (St. Louis, MO), shares Co-PIs responsibilities with Dr. Sorajja in US, while Dr. Vlasis Ninios, an interventional cardiologist at Interbalkan Medical Center (Thessaloniki, Greece), and Dr. Lenard Conradi, cardiothoracic surgeon at University Hospital Cologne (Cologne, Germany), share Co-PIs responsibilities in Europe.