4C Medical Technologies commenced enrolment in its ATLAS pivotal trial evaluating its AltaValve system. ATLAS (a transseptal left atrial system for the treatment of mitral regurgitation, or MR) evaluates AltaValve’s safety and efficacy. Participants in the study have moderate-to-severe or severe MR and are unsuitable for surgery or transcatheter edge-to-edge repair (TEER).
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The trial features two separate, non-randomized cohorts. One cohort includes patients with moderate/severe mitral annular calcification (MAC). The other — the primary cohort — includes patients with no or mild MAC. Dr. Yoshi Kaneko of Barnes-Jewish Hospital (St. Louis) and Dr. Paul Sorajja of Minneapolis Heart Institute serve as co-principal investigators. Dr. Ron Waksman of Medstar Washington Hospital Center (Washington, D.C.) serves as steering committee chair for ATLAS.
In Europe, Dr. Vlasis Ninios of Interbalkan Medical Center (Greece) and Dr. Lenard Conradi of University Hospital Cologne (Germany) share co-principal investigator responsibilities.
“We are excited to have successfully enroled the first US patients in the ATLAS trial,” said Sorajja. “It is an intuitive and predictable procedure with a repositionable implant that is very much needed for the treatment of patients worldwide.”
Minneapolis-based 4C designed its transcatheter mitral valve replacement (TMVR) technology to address MR. MR can lead to heart failure or death if untreated. The company received FDA breakthrough device designation for the system earlier this year.
Due to the complexity of the valve’s anatomy and comorbidities, limited medical therapies currently exist for MR. AltaValve could enter a market currently led by the Abbott MitraClip transcatheter mitral valve repair system.
In a news release, Waksman called AltaValve the first atrial fixation TMVR device designed to minimize the challenges of sub-valvular TMVRs. Sorajja touted the system’s potential to “offer the broadest applicability for wide range of pathologies.”
“It takes significant dedication and a lot of teamwork to take an innovative solution to treat MR from ideation to a global pivotal trial. We are very grateful for such strong support from key opinion leaders worldwide who are helping us carry our novel AltaValve System through pivotal trial with a goal of delivering safe and effective treatment solution for patients suffering from MR,” said Saravana Kumar, CEO and President at 4C Medical.
