TAVR with Edwards Lifesciences valve for severe AR linked to ‘encouraging’ data
![Performing transcatheter aortic valve replacement (TAVR) with the J-Valve transcatheter heart valve (THV) may help limit the risk of coronary artery obstruction (CAO) in high-risk patients, according to a new study published in Clinical Interventions in Aging.[1]](/sites/default/files/styles/top_stories/public/2024-10/screenshot_2024-10-01_at_2.16.21_pm.png.webp?itok=kSiGReBW)
Transfemoral transcatheter aortic valve replacement (TAVR) with the J-Valve System is associated with positive one-year outcomes in patients with symptomatic severe aortic regurgitation (AR), according to new data presented at New York Valves 2026. The findings were simultaneously published in JSCAI, the flagship journal of the Society for Cardiovascular Angiography and Interventions (SCAI).
The J-Valve Transfemoral Early Feasibility Study included data from 25 patients with symptomatic, severe, native AR. The mean age was 80.6 years old, and 76% of patients were men. All patients underwent transfemoral TAVR at one of eight U.S. facilities.
Overall, successful implants occurred for 92% of patients and the study’s primary endpoint—a composite of all-cause death or disabling stroke within 30 days—occurred in 8%. No cardiovascular deaths were reported. Two patients experienced a stroke and two patients required a permanent pacemaker.
After one year, non-trace AR was present in 95.5% of patients. Mild AR, on the other hand, was present in the other 4.5%. The mean gradient after one year was 5.5 mm Hg and the mean effective orifice area was 2.48 cm2. Reverse left ventricular modeling was evident at 30 days and it persisted after one year.
“Severe native AR is a difficult disease to treat with transcatheter therapy,” first author Dean J. Kereiakes, MD, chair of The Christ Hospital Heart and Vascular Institute in Cincinnati, said in a statement from SCAI. “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 one year. 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.”
These patients will be followed for a total of five years.
J-Valve technology now owned by Edwards Lifesciences
In 2024, Edwards Lifesciences agreed to acquire JC Medical, the company behind the J-Valve System, from Genesis MedTech. This acquisition is believed to be the primary reason Edwards was later blocked from acquiring JenaValve, another TAVR company focused on AR treatments, by the Trump Administration.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.