Edwards Lifesciences has announced that enrolment is complete in the computed tomography (CT) imaging substudy within the PARTNER 3 trial of the Sapien 3 valve.
This randomised 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 a press release, enrolment in the PARTNER 3 main study of the Sapien 3 valve in low-risk patients had already been completed. The company, according to a press release, anticipates that data from the PARTNER 3 trial will be presented at the 2019 American College of Cardiology Scientific Session and expects to receive FDA approval for the indication late that year.
Additionally, Edwards is studying the Sapien 3 Ultra system as part of a single-arm multicentre trial of up to 30 intermediate-risk patients. These data will be used to supplement the European regulatory filing for the Sapien 3 Ultra system. Edwards now expects that the European launch of the Sapien 3 Ultra system will occur later this year.