This article is more than 5 years old. Information may no longer be current.
FDA approves expanded-indication study of TAVR valve
Click Here to Manage Email Alerts
Edwards Lifesciences announced that it received FDA approval to conduct an expanded-indication study of the Sapien 3 transcatheter aortic heart valve.
Patients enrolled in the new PARTNER III trial will undergo random assignment to receive the Sapien 3 valve or open surgical valve replacement. The investigational device exemption (IDE) study will enroll elderly patients with severe, symptomatic aortic stenosis. Eligible patients must be aged 65 years or older and have a Society of Thoracic Surgeons risk score of less than 4%, according to a company press release.
Approximately 1,300 patients at up to 50 sites are expected to be enrolled. The study will also include a 400-patient substudy to evaluate leaflet motion in tissue heart valves.
“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,” Larry L. Wood, corporate vice president, transcatheter heart valves, Edwards Lifesciences, stated in the release.
Disclosure: Wood is an employee of Edwards Lifesciences.