Washington, D.C. — The Federal Trade Commission is taking legal action against Edwards Lifesciences over its plans to acquire JenaValve, raising concerns about potential antitrust violations in the medical device industry. The FTC argues that this acquisition could stifle competition in the market for transcatheter aortic valve replacement devices designed for treating aortic regurgitation.
In July 2024, Edwards Lifesciences announced intentions to purchase JenaValve and JC Medical, two notable developers in the transcatheter aortic valve replacement sector. Edwards completed the acquisition of JC Medical in August, paying approximately $320 million, and the FTC warns that if it also greenlights the proposed $945 million acquisition of JenaValve, it would combine the only two companies currently conducting clinical trials in the United States for TAVR devices aimed specifically at aortic regurgitation.
JenaValve’s Trilogy Heart Valve System, used for severe cases of aortic regurgitation, is under evaluation in the ongoing ALIGN-AR pivotal trial. This device previously gained approval in Europe as the first CE-marked solution for the condition in 2021. Meanwhile, JC Medical’s J-Valve Transfemoral has received a breakthrough device designation from the Food and Drug Administration and is presently being examined in the JOURNEY pivotal trial.
According to Daniel Guarnera, director of the FTC’s Bureau of Competition, the proposed merger would significantly threaten competition in the market. Guarnera emphasized that Edwards’ intention to dominate the TAVR device space for aortic regurgitation could hinder innovation and eliminate the competitive forces that drive advancements in the field.
In response to the FTC’s lawsuit, Edwards has expressed disagreement, claiming that the acquisition would actually enhance the availability and innovation of treatments for patients affected by aortic regurgitation. The company plans to continue with regulatory processes and anticipates a decision by the first quarter of 2026.
The legal complaint, seeking preliminary relief, was submitted to the U.S. District Court for the District of Columbia to prevent the transaction while an administrative review takes place. As the FTC moves forward, Edwards has updated its financial forecasts for 2025; while revenue expectations remain steady, the company has increased its Earnings Per Share guidance range from $2.40 to $2.50 up to $2.45 to $2.55.
JenaValve is also backing Edwards in contesting the FTC’s position, asserting confidence in the rationale behind the acquisition. A spokesperson highlighted that the deal aims to bring significant benefits to the many patients suffering from aortic regurgitation.
As the global market for TAVR devices grows, reaching a projected valuation of $14.9 billion by 2034 from $6.8 billion in 2024, stakeholders in the industry are closely monitoring how this legal battle unfolds. The outcome could influence not only market dynamics but the pace of innovation within this critical area of healthcare.
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