AltaValve EFS Studies Atrial Fixation TMVR to Treat Severe Mitral Regurgitation 

April 23, 2026—The 1-year outcomes from an early feasibility study (EFS) of the AltaValve system (4C Medical Technologies Inc.) showed that atrial fixation transcatheter mitral valve replacement (TMVR) provided sustained clinical benefits in the treatment of patients with severe mitral regurgitation (MR).

The findings from the EFS were presented as part of the late-breaking clinical science data at the Society for Cardiovascular Angiography & Interventions (SCAI) 2026 scientific sessions.

According to the SCAI press release, the AltaValve EFS is a prospective, multicenter, single-arm study that evaluated the safety and performance of the device and comprised 30 patients with symptomatic MR (≥ 3+) who were at high surgical risk or unsuitable for other transcatheter therapies because of anatomy. The study population was 63% female, with a mean age of 77.0 ± 6.2 years.

SCAI advised that 13 patients were treated through a transapical approach and 17 through a transseptal approach, as determined by the patient’s peripheral blood vessel health. Safety, performance, functionality, and quality of life outcomes were assessed at baseline, discharge, 30-day, 6-month, and 1-year follow-up.

As summarized in the press release, the study found that atrial-fixation TMVR reduced MR in 97% of cases.

• At 1 year postintervention, TMVR reduced and maintained MR to mild severity in 95% of patients, resulting in little to no discomfort when participating in physical activity.
• Heart ultrasound showed that treatment sustained the percentage of blood pumped by the left ventricle per beat (53% at 1 year vs 54% at baseline) along with the average pressure across the mitral valve (4.0 mm Hg) and left ventricular outflow tract (1.8 mm Hg).
• Functional outcomes also improved, with the 6-minute walk test increasing by 43 meters on average.
• There were no instances of complications like stroke, device migration, new atrial fibrillation, life-threatening bleeding, or need for pacemaker replacement.

“This is the first time we are presenting the durability and hemodynamic assessment of atrial-fixation TMVR performance at 1-year follow-up, providing us with qualitative data on valve performance,” commented Konstantinos Voudris, MD, in the SCAI press release. “Our findings suggest excellent valve performance, sustained positive outcomes, and a low rate of complications, as health benefits did not taper off at 1 year post TMVR. We hope this can become a durable, efficient, and therapeutic option for a broad patient population with limited treatment options.”