The U.S. Food and Drug Administration today approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow to aorta, the body’s main artery) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged valves. These transcatheter valves – Sapien 3, Sapien 3 Ultra, CoreValve Evolut R and CoreValve Evolut PRO – were previously indicated only for patients at intermediate or higher risk for death or major complications during open-heart surgery. In low risk patients, open-heart surgery has been the standard-of-care for aortic valve replacement. However, the procedure to insert a transcatheter heart valve is less invasive, and involves a smaller incision and shorter recovery time than open-heart surgery. The FDA is the first medical products regulatory body in the world to expand the indication for these devices to patients at low risk for death or major complications associated with open-heart surgery.
“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,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health. “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 in both the premarket and postmarket settings to ensure patients have access to high-quality, safe, and effective medical devices.”
The incidence of aortic valve stenosis increases with age. As the aortic valve opening narrows, the heart must work harder to pump blood to the body. Occurring in about 3% of Americans over age 75, severe aortic valve stenosis can cause fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), cardiac arrest or death. Patients with severe aortic valve stenosis generally need to undergo heart valve replacement to improve blood flow through their aortic valve.
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In a clinical study to evaluate safety and effectiveness, 503 patients with severe aortic stenosis at low risk for surgical complications were randomly selected to have aortic valve replacement with the Sapien 3 transcatheter heart valve, and 497 were randomly selected to have aortic valve replacement with traditional open-heart surgery using an approved surgical tissue valve. In a separate study, 734 low-risk patients with severe aortic stenosis were randomly selected to have aortic valve replacement with the CoreValve Evolut R or CoreValve Evolut PRO transcatheter valve, and 734 were randomly selected to have aortic valve replacement with traditional open-heart surgery using an approved surgical tissue valve. At an average of 15-17 months follow-up, when outcomes (such as all-cause mortality or stroke) for transcatheter and surgical patients were compared, the transcatheter heart valve achieved comparable results to surgery, demonstrating a reasonable assurance of safety and effectiveness of the transcatheter heart valves in low surgical risk patients.