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Market for aortic valve replacement products: AFCA files request for examination with Cartel Court of Edwards Lifesciences/JenaValve Technology merger

The Austrian Federal Competition Authority (AFCA) was notified of the planned merger between Edwards Lifesciences and JenaValve Technology on 12 September 2024. On 24 October 2024, the AFCA filed an application for an in-depth (Phase II) review of the merger with the Cartel Court owing to competition concerns.

Aim of the notification

The notifying party, Edwards Lifesciences Corp., USA (“Edwards”), intends to acquire all of the shares in and sole control of the target company, JenaValve Technology, Inc., USA (“JenaValve”) (BWB/Z 6717).

Involved companies

JenaValve develops and sells a transcatheter aortic valve replacement product for the treatment of aortic regurgitation (TAVR-AR). This TAVR-AR valve is the only valve to treat aortic regurgitation currently approved in Europe.

Edwards develops and sells a transcatheter aortic valve replacement product for the treatment of aortic stenosis (TAVR-AS). Edwards recently acquired a company owning the rights to develop, manufacture and market a TAVR-AR valve outside China. The acquisition of this company (also) encompasses the right to market the TAVR-AR valve in Europe.

Competition concerns

After gathering large amounts of data and questioning competitors and customers, the AFCA had doubts about the new market definition. In the AFCA’s view, a joint market for the manufacture and distribution of TAVR-AR and TAVR-AS valves raises competition concerns since it strengthens the already strong market positions of the acquiring company.
In addition, there are also competition concerns with the only potential competitor being lost as a consequence of the planned merger, which would result in a bundling of the only TAVR-AR valve approved in Europe with the only other TAVR-AR valve currently approved (but only in China). It also seems likely that potential competitors would be severely hindered from entering the European or Austrian market by high entry barriers in the form of IP rights. There are fears that this would considerably reduce horizontal competition intensity as a result.

With these competition concerns in mind, the AFCA considered it necessary for the Cartel Court to conduct an in-depth review of the planned merger. The Federal Cartel Prosecutor has also filed a request for examination.