(Law360) The Federal Trade Commission filed suit Wednesday against Edwards Lifesciences Corp. over the company’s proposed $945 million purchase of JenaValve Technology Inc., arguing the deal would give Edwards control over both of the only firms with ongoing U.S. clinical trials developing an important heart valve replacement device.
The FTC’s Bureau of Competition director alleges that Edwards Lifesciences’ purchase would “eliminate the head-to-head competition that has spurred innovation for lifesaving artificial heart valves.” (Photo by Kristoffer Tripplaar/Sipa USA)(Sipa via AP Images)
While the lawsuit in D.C. federal court and the FTC’s concurrent in-house case challenge only the JenaValve deal, the allegations are intertwined with another transaction Edwards announced one day apart in July 2024, scooping up JC Medical. The JC Medical deal closed last August. And the agency argued that allowing Edwards ownership over both companies would give it control over the only firms in active U.S. clinical trials developing transcatheter aortic valve replacement devices, which treat a heart condition called aortic regurgitation, or AR.
“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 announcing the suit. “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 stood by the acquisition Wednesday.
“Edwards disagrees with FTC’s decision and believes it will limit the availability of an important treatment option for patients suffering from aortic regurgitation,” it said in a statement. “The company further believes the acquisition of JenaValve will accelerate the availability, adoption and continued innovation of a life-saving treatment for patients suffering from AR.”
According to the FTC announcement, over 8 million Americans suffer from AR, a condition that happens when the aortic valve doesn’t close properly, forcing blood to backflow into the heart. At the moment, the FTC said open heart surgery to replace the valve is the only U.S. Food and Drug Administration-approved procedure to treat the condition. TAVR-AR devices, it said, “offer a new and less invasive way to treat the condition.”
The lawsuit is the second FTC challenge to a medical device technology merger in recent months. It follows the agency’s March case contesting private equity firm GTCR BC Holdings’ $627 million purchase of Surmodics Inc., over concerns of reduced competition for hydrophilic coatings that reduce friction for medical devices like catheters and stents inserted into the human body.
On Wednesday, the FTC said JenaValve’s Trilogy is “poised” to become the first commercially marketed TAVR-AR device in the U.S.
“If Edwards acquires JenaValve, Edwards would gain control over the two most advanced TAVR-AR devices, the FTC complaint alleges,” the agency said in announcing the challenge. “FDA approval or commercialization of any other TAVR-AR device in the United States by another company, aside from Edwards and JenaValve, is not expected for the foreseeable future.”
According to the FTC, head-to-head competition between JenaValve and JC Medical has pushed both companies to accelerate their TAVR-AR development, to the benefit of patients.
“The competition concerns caused by Edwards’ dual acquisition strategy are predicated on Edwards owning both JenaValve and JC Medical simultaneously, but Edwards has elected to attempt to buy JenaValve while retaining its ownership of JC Medical,” the FTC said. “Edwards has not been willing to engage on divesting JC Medical to resolve the competition concerns with the proposed JenaValve acquisition, according to the complaint.”
According to the announcement, the FTC’s three commissioners, currently all Republicans, voted unanimously to approve the in-house complaint and the federal court lawsuit seeking to block the transaction at least until the in-house case can decide the merits.
The FTC is represented in-house by Barrett J. Anderson, Laura R. Hall, Jordan S. Andrew, James Weiss, Lisa De Marchi Sleigh, Jay Tymkovich, Nathan Brenner, Habin Chung, Jacob Danziger, Evan R. Johnson, Wade Lippard, Betty Jean McNeil, Dylan P. Naegele, Elena Ponte, Michelle J. Seo and Hilla Shimshoni.
Counsel information for Edwards was not immediately available Wednesday.
The case is Federal Trade Commission v. Edwards Lifesciences Corp. et al., case number 1:25-cv-02569, in the U.S. District Court for the District of Columbia.