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Edwards Lifesciences Delays European Launch of Sapien 3 Ultra

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Edwards’s European Sapien 3 Ultra launch delayed

On March 21, 2018, Edwards Lifesciences (EW) announced that it expects to launch its Sapien 3 Ultra System in Europe in late 2018 instead of early 2018. The Sapien 3 Ultra’s US launch is still expected in late 2018. The company asserted that the delay would not impact its 2018 guidance. Edwards expects THV (transcatheter heart valve) therapy sales of $2.1 billion–$2.4 billion in fiscal 2018. For more on its guidance, read What’s Expected for Edwards Lifesciences in 2018.

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Why the delay?

Edwards Lifesciences stated that it has pushed back the European launch of Sapien 3 Ultra because it plans to supplement the device’s European regulatory filing with data from a study of 30 intermediate-risk surgical-valve-replacement patients.

The company also announced that it has completed enrolments for its PARTNER 3 trial sub-study of the Sapien 3 valve, which will compare low-risk surgical-valve-replacement patients’ leaflet mobility with surgical valves and Sapien 3 valves. According to Edwards Lifesciences, Sapien 3 Ultra is a step ahead of Sapien 3, boasting some design enhancements that the company believes could lower paravalvular leak rates and reduce the number of steps in a procedure.

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