Edwards Lifesciences has announced that it has received Investigational Device Exemption (IDE) approval from the FDA to initiate a single-arm, non-randomised clinical trial of its Sapien 3 transcatheter aortic valve implantation (TAVI) device for the treatment of intermediate risk patients with severe symptomatic aortic stenosis. The company also completed enrolment in its US clinical trial of Sapien 3 valve in the treatment of high-risk or inoperable patients.
According to a press release, the Sapien 3 valve is the only transcatheter heart valve available to US patients that can be delivered through a low-profile 14-French expandable sheath (eSheath). It also has an outer skirt to provide a seal to address paravalvular leak. The Sapien 3 valve can be implanted with the transfemoral approach through an incision in the leg, as well as alternative access approaches. It is an investigational device that is not available commercially in any country; CE Mark approval in Europe is anticipated in the near future.
The press release reports that the new US trial of the Sapien 3 valve will enrol up to 1,000 patients with a Society of Thoracic Surgeons score of 4–8%, which indicates the average predicted risk of operative mortality at 30 days. All enrolled patients can receive a Sapien 3 valve.
“The Sapien 3 valve is a significant advancement, and we’re excited to make progress toward bringing this sought-after transcatheter therapy to US patients. It represents a big step toward fulfilling the promise of a simpler procedure with fewer complications and faster patient recovery,” said Larry L Wood, corporate vice president, transcatheter heart valves. “Last year, we completed enrolment in the first US randomised controlled trial involving intermediate risk patients with severe aortic stenosis. This unique dataset of 2,000 patients receiving surgery or transcatheter valve replacement will provide a thorough baseline comparison for this new study of the Sapien 3 valve in intermediate risk patients.”