Edwards Lifesciences delays Sapien 3 Ultra debut in Europe until later this year

Edwards Lifesciences (NYSE:EW) said yesterday that it’s hoping to launch its Sapien 3 Ultra replacement heart valve in Europe this year, after it submits data from a small, single-arm study of the device.

Last fall, when it introduced its latest transcatheter aortic valve replacement, Edwards said it expected to win CE Mark approval by the end of 2017. Sapien 3 Ultra’s updates include a taller outer skirt and an “on-balloon” delivery design, the Irvine, Calif.-based company said at the time.

The timeline for the Sapien 3 Ultra device was pushed back until “later in 2018,” Edwards said yesterday, to allow for submission of data from a 30-subject study of patients at intermediate risk from surgical valve replacement to supplement the CE Mark application.

The change is not expected to alter sales guidance and the expectation for a U.S. launch is still late this year, Edwards said.

The company also said it’s closed enrollment in a sub-study from the Partner 3 trial of the original Sapien 3 valve, a randomized, computed tomography imaging study comparing leaflet mobility in both Sapien 3 and surgical valves in low-risk patients.

Data from the main Partner 3 study is slated for release a year from now, at the 2019 meeting of the American College of Cardiology in New Orleans, Edwards said, adding that it “expects to receive FDA approval for the indication late that year” for Sapien 3.

The post Edwards Lifesciences delays Sapien 3 Ultra debut in Europe until later this year appeared first on MassDevice.

from MassDevice http://ift.tt/2pAUJC2