TAVR valve for AR , a recent Edwards acquisition, delivers long-term value
The J-Valve System, a transcatheter aortic valve replacement (TAVR) valve specifically designed to treat aortic regurgitation (AR), is associated with positive long-term outcomes, according to a new 10-year analysis published in JACC: Cardiovascular Interventions.[1]
Back in 2024, Edwards Lifesciences agreed to acquire JC Medical, the company behind the J-Valve System, from Genesis MedTech. However, Genesis MedTech kept the rights to develop, manufacture and commercialize the J-Valve technology in China. This acquisition is believed to be the primary reason Edwards was later blocked from scooping up JenaValve, another TAVR company focused on AR treatments, by the Trump Administration.
The J-Valve System has not yet received Food and Drug Administration (FDA) approval. However, it did already receive the FDA’s breakthrough device designation; this suggests the agency sees considerable potential in technology and is working with Edwards to help the company secure that full approval.
This specific analysis included 98 patients who received the J-Valve System in China. While 62 patients received the valve to treat their severe aortic stenosis (AS), the other 36 patients received it to treat their severe AR. The mean age was 73.9 years old. The 10-year mortality rates were 29% for AS patients and 38.9% for AR patients. Looking at the overall group, 10-year rates of cardiovascular mortality, stroke and permanent pacemaker implantation were 15.3%, 9.2% and 12.2%, respectively.
The group also examined follow-up echocardiography data when it was available. Transvalvular pressure gradients were higher and valve areas were smaller for AS patients. Moderate to severe structural valve deterioration (SVD) occurred in 18.3% of patients and was much more likely for those who presented with severe AS than it was for those who presented with severe AR. Bioprosthetic valve failure (BVF), meanwhile, occurred in 12.2% of patients; it was also more likely in patients who presented with severe AS.
These differences in SVD and BVF may have been due to the fact that AR patients typically have little or no aortic valve calcification, which makes the implant easier. AS patients, on the other hand, may present with uneven calcification levels that are harder to adapt to during implant procedures.
The rate of aortic valve reinterventions was low for both groups, the authors added.
“This long-term follow-up study provides reassurance that TAVR with the J-Valve for both AS and AR provides similar excellent long-term outcomes,” wrote first author Yuqiang Wang, MD, a researcher with the department of cardiovascular surgery at West China Hospital., and colleagues.
Click here for the full analysis.
For additional context, read about a recent analysis that described treating AR as TAVR's "next frontier."
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.