The Federal Trade Commission (FTC) recently announced its intention to block Edwards Lifesciences鈥� acquisition of JenaValve, a medical device company focusing on transcatheter aortic valve replacement for aortic regurgitation (TAVR-AR). The initial complaint brought against Edwards Lifesciences by the FTC includes concerns over competitive dynamics for the TAVR-AR market, as JenaValve and Edwards Lifesciences鈥� subsidiary JC Medical are the only two companies currently developing the medical devices. If Edwards Lifesciences is allowed to complete the acquisition, this would enable the company to become the sole manufacturer of the most advanced devices on the market for TAVR-AR, which could adversely affect patient outcomes due to the lack of active competition.
The acquisition of JenaValve was initially announced in July 2024, subject to regulatory approval. JenaValve is in the process of obtaining US Food and Drug Administration (FDA) approval for the first transcatheter aortic valve designed to address aortic regurgitation. Existing transcatheter aortic valve replacements are only indicated for aortic valve stenosis, with other companies, such as Medtronic and Abbott, active in the market. However, neither Abbott nor Medtronic have indicated plans to develop a heart valve for the treatment of aortic valve regurgitation, leaving Edwards Lifesciences and JenaValve as the only two companies with any short-term plans to enter the market. The FTC therefore intends to block the acquisition to allow for competition. Edwards Lifesciences has already released a statement declaring its intent to contest this ruling.
GlobalData estimates the current US TAVR market to be worth $3.2 billion, and forecasts it to grow at a compound annual growth rate (CAGR) of 6.56% from 2024 to 2034. The current market forecast does not include any TAVR-AR devices, as these have not yet made it to market. JenaValve expects to have the first TAVR-AR valve approved by the end of 2025. According to GlobalData estimates, there are 1.6 million adults in the US with some degree of aortic valve regurgitation. Depending on the severity of the regurgitation, treatments range from lifestyle modification to major open-heart surgery. A TAVR-AR treatment could address more severe cases without the need for highly invasive surgical procedures.
TAVR-AR devices are likely to be a significant step forward for the treatment of aortic valve regurgitation. However, the FTC inquiry into the acquisition of JenaValve could delay the entry of both products into the market. Although Edwards Lifesciences has already contested the case, it remains to be seen if the company can successfully prove to the FTC that it will continue to innovate within the TAVR-AR market space, despite having the only devices on the market.
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By GlobalData
