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.
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.