FTC challenges ‘anticompetitive’ TAVR acquisition
The U.S. Federal Trade Commission (FTC) is working to stop Edwards Lifesciences from completing its acquisition of JenaValve, highlighting concerns that the deal would be combining the only two medtech companies currently focused on developing transcatheter aortic valve replacement (TAVR) devices for the treatment of aortic regurgitation (AR).
In July 2024, Edwards announced its intention to acquire JenaValve and Endotronix, a medtech company focused on heart failure, for a combined $1.2 billion. JenaValve has already gained CE mark approval for its Trilogy Heart Valve System, a valve specifically built for the treatment of symptomatic severe AR. The company has been working toward gaining U.S. Food and Drug Administration approval for the device for years now, and it has felt like that moment could be coming sooner rather than later.
The FTC’s problem with this deal, however, is that Edwards has also agreed to acquire JC Medical, another company focused on treating AR. From the agency’s perspective, if Edwards acquires both JenaValve and JC Medical, it means that all known treatment options for AR in the hands of a single medtech company.
The JenaValve Transcatheter Heart System on display at TCT 2023. Photo by Dave Fornell.
“Edwards’ attempt to buy the U.S. market for TAVR-AR devices would eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves,” Daniel Guarnera, director of the FTC’s Bureau of Competition, said in a statement. “The FTC is taking action to stop this anticompetitive deal and ensure that JenaValve and Edwards’ JC Medical subsidiary continue competing to innovate, expand treatment eligibility and keep down costs. Americans deserve all the benefits that come from competition between medical device makers, just as they do in other markets.”
Edwards shared a statement of its own, saying it disagrees with the FTC’s decision.
“AR is a deadly and progressive disease that affects a significant and growing number of patients, many of whom currently have limited treatment options,” the company said. “Edwards intends to continue to pursue regulatory approval of the acquisition and estimates a final determination by the end of Q1 2026.”
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.