Judge blocks Edwards’ JenaValve acquisition—FTC calls it a ‘major win’ for Trump administration

The U.S. Federal Trade Commission (FTC) has successfully stopped Edwards Lifesciences from following through with its $945 million acquisition of JenaValve. 

Edwards, already one of the biggest heart valve companies in the United States, first announced its intention to acquire JenaValve back in July 2024. The company hoped to add JenaValve’s Trilogy Heart Valve System for severe aortic regurgitation (AR) to its transcatheter aortic valve replacement (TAVR) portfolio. 

Why the FTC sued to stop this acquisition

Edwards previously acquired JC Medical, the only other medtech company currently focused on developing TAVR technology to treat AR. The FTC had concerns about Edwards scooping up both JC Medical and JenaValve, saying it could “eliminate head-to-head competition.” It then filed a lawsuit to stop the JenaValve acquisition in its tracks. 

Edwards and JenaValve both urged the court to dismiss this lawsuit. The judge, however, seems to have been swayed by the FTC’s argument.

“This is a major win for the Trump-Vance administration,” an FTC spokesperson said in a statement. “We will never stop working to promote innovation, lowering healthcare costs and saving American lives.”

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jenavalve TAVR valve for aortic regurgitation acquired by Edwards

The JenaValve Transcatheter Heart System on display at TCT 2023. Photo by Dave Fornell.

Edwards Lifesciences responds to the court’s decision

Edwards was quick to release its own statement about the news, confirming that it would not be going through with this acquisition. 

“Edwards disagrees with the decision and believes that the acquisition would have been in the best interest of a large, growing and underserved group of patients,” the company wrote. “AR is a deadly, progressive disease. It is typically under-detected and under-referred and carries very high mortality if left untreated. As a company pioneering first-of-its-kind innovations for unaddressed structural heart patient groups, Edwards remains committed to leading the AR therapy for patients in need.”

JenaValve’s future

JenaValve and its Trilogy Heart Valve System are suddenly red-hot commodities in the medtech industry. While the Trilogy system has not yet gained U.S. Food and Drug Administration (FDA) approval, it is largely believed that approval could come in the near future. 

Now that this lawsuit has been decided, could FDA approval be on the horizon? Will Medtronic, Johnson & Johnson or another leader in the heart valve space step forward and try to acquire JenaValve? 

For now, only time will tell. 

Michael Walter
Michael Walter, Managing Editor

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.

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