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Latest Sapien Valve Gets EU Go-Ahead, But Germany Will Have To Wait

 
• By David Filmore

Edwards Lifesciences plans a "controlled rollout" of its Sapien 3 Ultra transcatheter heart valve replacement in Europe following the CE mark announced Nov. 16. But a patent dispute with Boston Scientific will prevent Edwards from launching it in Germany.

The Sapien 3 Ultra transcatheter aortic heart valve replacement will help improve Edwards Lifesciences Corp. competitive position in the European TAVR market, the company says. But it won't be a factor, at least for the time being, in the largest EU device market, Germany.

The next-gen TAVR device gained a CE mark, Edwards announced Nov. 16. The company is now initiating a "controlled rollout" of the device in Europe, where the prior-generation Sapien 3...

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