Latest Sapien Valve Gets EU Go-Ahead, But Germany Will Have To Wait
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.
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Sapien 3 is now indicated to treat failed right ventricular outflow tract conduits, surgical bioprosthetic pulmonary valves and transcatheter aortic valves.
Edwards Lifesciences is giving up on the Centera transcatheter aortic valve replacement (TAVR), despite promising clinical results, to focus on its Sapien TAVR line. The company reported overall revenue of $1.1bn in the second quarter of 2019, representing 14% year-over-year growth, driven by 18% growth in sales of Sapien systems.
2018 Earnings Spotlight: Transcatheter Valve Repair Remains Big Drivers For Medtronic, Edwards, Abbott
Reported sales and earnings from the publicly traded cardiovascular device companies in 2018 were generally strong, led by transcatheter aortic valve replacement devices, but some sectors of the industry, especially ventricular assist devices and peripheral drug-coated balloons, face significant challenges. Here's a recap of results from the cardio device companies that have reported so far, with a focus on Medtronic, Edwards, and Abbott.