Edwards Lifesciences has obtained approval from the US Food and Drug Administration (FDA) to expand indication study of its Sapien 3 transcatheter aortic heart valve.
The approval enables the firm to enroll elderly patients with severe and symptomatic aortic stenosis (AS) in the investigational device exemption (IDE) trial.
The firm will randomize the patients with at least 65 years old in the new Partner III study to receive either the Sapien 3 valve or open surgical valve replacement.
Partner III trial is a non-inferiority study with a one-year composite endpoint, which includes death, stroke and rehospitalization.
Edwards plans to enroll around 1,300 patients at about 50 sites in the trial, which is expected to begin in the second quarter of this year.
In addition, the trial will comprise 400-patient sub-study that will assess leaflet motion in tissue heart valves through using advanced imaging.
Edwards transcatheter heart valves corporate vice-president Larry Wood said: "If this trial is successful, it will allow heart teams to choose a treatment approach that is best suited to every patient’s individual need.
"We are pleased to begin this important study of the Sapien 3 transcatheter valve to evaluate its safety and effectiveness in a broader group of elderly patients suffering from this deadly disease."
In 2015, the Sapien 3 received FDA approval to treat high-risk patients suffering from severe and symptomatic AS.