J-Valve TF THV System for Treating Severe Aortic Regurgitation Evaluated in EFS

June 28, 2026—The Society for Cardiovascular Angiography & Interventions announced 1-year outcomes in patients with symptomatic severe aortic regurgitation (AR) after treatment with the investigational J-Valve transfemoral (TF) transcatheter heart valve system.

The findings from the J-Valve TF early feasibility study were presented at the New York Valves 2026 conference and simultaneously published by Dean J. Kereiakes, MD, et al in JSCAI. The J-Valve study was funded by the device’s developer, JC Medical, Inc., an affiliate of Edwards Lifesciences LLC.

According to SCAI, the study evaluated the safety and effectiveness of the J-Valve system in patients with severe native AR who were deemed high risk for surgical aortic valve replacement.

The prospective, single-arm, multicenter study enrolled 25 patients (mean age, 80.6 years) at eight centers in the United States. All patients had symptomatic severe native AR and were deemed high risk for surgical aortic valve replacement by a local multidisciplinary heart team. Successful valve implantation occurred in 92% of patients, noted SCAI.

As summarized in the SCAI press release, the study demonstrated that the primary endpoint (a composite of all-cause mortality or disabling stroke at 30 days) occurred in two patients (8.0%). All-cause mortality was 4.0% at 30 days and 1 year, with no cardiovascular-related deaths. Additionally, patients experienced sustained improvements in symptoms and health status.

SCAI further reported that at 1 year, the New York Heart Association functional class improved in 72.7% of patients, with 95.5% in class I or II, and reverse left ventricular remodeling was evident at 30 days and sustained through 1 year.

Follow-up through 5 years is planned, and more definitive evidence is expected from the larger, ongoing JOURNEY trial, advised SCAI.

“Severe native AR is a difficult disease to treat with transcatheter therapy,” commented Dr. Kereiakes in the SCAI press release. “However, this early feasibility study for J-Valve is encouraging because it shows that a dedicated device designed for AR can achieve sustained valve performance, meaningful symptom improvement, and evidence of reverse left ventricular remodeling at 1 year.”

Dr. Kereiakes added, “While larger studies are needed, these data support continued evaluation of the J-Valve system as a potential option for patients with severe AR and limited alternatives.”