FTC Fines Edwards $10M Over JC Medical Deal

The Federal Trade Commission (FTC) said it’s secured $12 million in penalties in a settlement with Edwards Lifesciences and Genesis MedTech.

Edwards and former Genesis subsidiary JC Medical will pay a $10 million penalty, and Genesis will pay a $2 million penalty. The settlement addresses charges that Edwards acquired JC Medical from Genesis without complying with the Hart-Scott-Rodino Act (HSR)’s notification and waiting period requirements.

The allegations charged that Edwards and Genesis looked to avoid federal antitrust review of the acquisition of JC Medical, which was amid trials to bring to market transcatheter aortic valve replacement devices to treat aortic regurgitation (TAVR-AR). According to the FTC’s complaint, Edwards and Genesis intentionally structured their deal to avoid compliance with the HSR Act—its waiting period allows antitrust agencies time to assess the transaction for possible competitive harm.

In July 2024, the FTC said Edwards bought JC Medical without filing under HSR, then a day later tried to acquire JC Medical’s only competitor, JenaValve. The agency’s rationale for blocking the transactions was that Edwards would’ve owned the only two companies in the U.S. with TAVR-AR devices in clinical trials.

The FTC then sued to block Edwards’ transaction for JenaValve, alleging the deal was anticompetitive. In January 2026, the District of Columbia granted the FTC’s request for a preliminary injunction after a six-day hearing.

Edwards nixed the deal for JenaValve shortly thereafter.

More about the FTC allegations

According to the complaint, Edwards was concerned HSR review would delay closing on JC Medical’s acquisition, particularly amid concurrent negotiations to acquire JenaValve.

Edwards and Genesis resolved that Edwards would pay $115 million (plus milestone payments) for JC Medical to fall just below the $119.5 million minimum threshold required at the time to trigger HSR review. However, the complaint alleged Edwards also agreed to a $25 million investment in Genesis related to the JC Medical acquisition.

The FTC said the transactions between the companies met the mandatory HSR threshold because the combination totaled over $119.5 million.

Edwards now cannot, without advanced written notification to the FTC, acquire ownership interest in a company that sells a TAVR-AR device, is amid a U.S. clinical trial for a TAVR-AR device, or received an IDE from the FDA to conduct trials on a TAVR-AR device in the U.S. The company must also design, maintain, and operate an antitrust program to ensure compliance.