The Federal Trade Commission (FTC) has moved to block Edwards Lifesciences Corp.'s proposed acquisition of JenaValve Technology, Inc., citing concerns that the deal would limit patient access to important medical devices for treating aortic regurgitation, a serious heart condition.
According to the FTC, in July 2024, Edwards reached agreements to acquire both JenaValve and JC Medical. These companies are considered the main competitors developing transcatheter aortic valve replacement devices (TAVR-AR) in the United States. Edwards completed its purchase of JC Medical in August 2024 and is now seeking to acquire JenaValve for $945 million. The FTC argues that combining these two firms would reduce competition in the TAVR-AR market, potentially leading to less innovation, lower product quality, and 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. Americans deserve all the benefits that come from competition between medical device makers, just as they do in other markets.”
More than eight million Americans have aortic regurgitation, which occurs when blood flows backward into the heart due to an improperly closing aortic valve. Currently, open-heart surgery is the only FDA-approved treatment for this condition in the United States. TAVR-AR devices offer a less invasive alternative.
JenaValve's Trilogy device could become the first TAVR-AR product available commercially in the U.S., according to information from regulators. If Edwards acquires JenaValve, it would control both leading products at an advanced stage of development; no other company is expected to bring such a device to market soon.
Direct competition between Edwards (through JC Medical) and JenaValve has pushed both firms to speed up their development efforts. The FTC claims that patients benefit from this rivalry as each company works toward clinical trials and commercialization.
The FTC also stated that its concerns stem from Edwards owning both JenaValve and JC Medical at once but noted that Edwards has not agreed to divest JC Medical as part of any remedy.
The Commission voted unanimously (3-0) to issue an administrative complaint and authorize legal action seeking a temporary restraining order and preliminary injunction against completing the transaction. The federal court filing was made in Washington D.C.'s District Court.
The agency clarified that issuing an administrative complaint signals it believes there may be a violation of law warranting further proceedings before an administrative law judge.
For more on how competition affects consumers or how complaints can be filed with regulators, readers can visit https://www.ftc.gov/about-ftc/what-we-do or learn about consumer rights at https://www.ftc.gov/news-events/topics/competition-antitrust.
