The FDA has expanded its indication for transcatheter aortic valve replacement (TAVR) to low-risk patients, the agency announced August 16, approving a handful of valves for an intervention that was previously limited to intermediate- and high-risk patients.
Among the valves that received premarket approval were Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO. Up to this point, the standard of care for low-risk aortic valve replacement candidates was open-heart surgery, and the FDA said in its statement that it’s the first regulatory body in the world to expand the indication for TAVR to patients at a low risk for death or major complications during such surgeries.
“This new approval significantly expands the number of patients that can be treated with this less-invasive procedure for aortic valve replacement and follows a thorough review of data demonstrating these devices are safe and effective for this larger population,” Bram Zuckerman, MD, director of the Office of Cardiovascular Devices at the FDA, said in the agency’s statement. “As the FDA assesses new medical technologies or expanded uses for previously approved products such as these, the agency remains committed to evaluating evidence from clinical trials and real-world clinical data both in the premarket and postmarket settings to ensure patients have access to high-quality, safe and effective medical devices.”
The FDA based its premarket approval of the four valves on two separate clinical studies. In the first, 503 and 497 low-risk patients with severe aortic stenosis were randomized to intervention with either the Sapien 3 valve or traditional open-heart surgery with a tissue valve, respectively. In the second, 734 low-risk patients assigned to TAVR with one of the Evolut valves were compared to 734 matched patients who underwent open-heart surgery.
At an average of 15-17 months follow-up, the results of both studies suggested intervention with TAVR was at least as successful as intervention with open-heart surgery, proving the safety and efficacy of the less-invasive approach. Edwards' trial of the Sapien 3 proved TAVR with the device was superior to surgery; Medtronic's showed non-inferiority.
The FDA said it’s requiring both valve manufacturers to continue following up with patients enrolled in the randomized studies for at least a decade, to “further monitor transcatheter aortic valve safety and effectiveness, including long-term valve durability.” The companies will also participate in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.