WASHINGTON, D.C. — The Federal Trade Commission (FTC) has filed a complaint to stop Edwards Lifesciences Corp. from acquiring JenaValve Technology, Inc., citing fears the deal would significantly reduce competition in the market for lifesaving heart valve devices.
The FTC alleges the acquisition would give Edwards control over the only two companies currently conducting U.S. clinical trials for transcatheter aortic valve replacement devices designed to treat aortic regurgitation (TAVR-AR), a condition in which the aortic valve fails to close properly, allowing blood to flow backward into the heart. More than eight million Americans suffer from this potentially fatal condition, which is currently treated only through open-heart surgery. TAVR-AR devices promise a less invasive alternative.
The agency notes that Edwards recently completed its purchase of JC Medical — the other leading TAVR-AR developer — in July 2024. Its proposed $945 million acquisition of JenaValve would consolidate the two leading competitors, a move the FTC argues could stifle innovation, reduce product quality, and lead to higher prices.
“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,” said Daniel Guarnera, Director of the FTC’s Bureau of Competition. “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.”
According to the FTC, direct competition between JenaValve and JC Medical has driven faster development, clinical testing, and product improvements. JenaValve’s Trilogy system is positioned to become the first TAVR-AR device available in the U.S., but if Edwards gains control of both companies, the agency warns that future innovation and timely market entry could be jeopardized.
The Commission voted unanimously, 3-0, to issue an administrative complaint and authorize legal action, including a request for a temporary restraining order and preliminary injunction, to halt the transaction.
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