Edwards Completes Enrollment in PARTNER 3 Low-Risk CT Substudy
March 21, 2018—Edwards Lifesciences Corporation announced that enrollment is complete in the CT imaging substudy within the PARTNER 3 trial of Edwards' Sapien 3 valve. The randomized substudy is examining leaflet mobility of both the Sapien 3 valve and surgical heart valves in low-risk patients undergoing valve replacement for the treatment of severe aortic stenosis.
According to the company, enrollment was already complete for the PARTNER 3 main study of the Sapien 3 valve in low-risk patients. Edwards previously stated that it continues to anticipate that data from the PARTNER 3 trial will be presented at ACC 2019, the American College of Cardiology's 68th annual scientific session to be held March 16–18 in New Orleans, Louisiana. The company expects to receive US Food and Drug Administration approval for the indication in late 2019.
In addition, Edwards is studying the Sapien 3 Ultra system as part of a single-arm multicenter trial of up to 30 intermediate-risk patients that will support the European regulatory filing for the Sapien 3 Ultra system.
The company advised that it now expects that the European launch of the Sapien 3 Ultra system will occur later in 2018 and it continues to expect the introduction of this system in the United States in late 2018.