US-based 4C Medical has enrolled the first patients in a pivotal trial for its transcatheter mitral valve replacement (TMVR) device, the AltaValve System, for treating moderate or severe mitral regurgitation (MR).
In MR, blood flows backwards through the mitral valve into the atrium with each contraction of the left ventricle. Left untreated, the condition can result in heart failure and death.
4C Medical’s AltaValve System received dual breakthrough designations from the US Food and Drug Administration (FDA) in May 2024 for treating MR and mitral annular calcification (MAC).
The ATLAS trial (NCT06465745) will run for seven years and plans to enrol 450 patients who are unsuitable for surgery or transcatheter edge-to-edge repair. It will evaluate the safety and performance of the AltaValve System for treating moderate or severe MR in two separate, non-randomised cohorts, with the primary arm including patients with moderate or no MAC, and an experimental arm of patients with moderate-to-severe MAC.
The study’s primary outcome measure is the creation of a composite of all-cause mortality or heart failure hospitalisation over 12 months. Secondary outcome measures include the device’s technical success and quality of life (QoL) changes between six months and one year on the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Dr Ron Waksman, chair of the ATLAS trial’s steering committee, claims the AltaValve System is the first atrial fixation TMVR device that is designed to minimise 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.
4C Medical said the trial of its AltaValve System, which is currently only available for investigational use and has not been approved for use outside of clinical trials, is intended to support the attainment of CE mark in Europe and market approval from the FDA.
"We are excited to have successfully enrolled the first US patients in the ATLAS trial,” said Paul Sorajja, interventional cardiologist at Minneapolis Heart Institute and co-principal investigator of the trial.
“I am particularly excited as the AltaValve System is designed to offer the broadest applicability for 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."
According to a report by GlobalData, the TMVR market in the US was worth around $480m in 2023 and is forecast to reach a valuation of around $1bn by 2031.
In July 2024, Edwards Lifesciences announced plans to acquire Israeli company Innovalve Bio Medical for around $300m to advance its early-stage TMVR business.
