On August, 16, 2019, the US Food and Drug Administration (FDA) 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, MD, 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.

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.

Like open-heart valve replacement surgery, treatment with transcatheter heart valves is associated with a potential risk of serious complications. The serious complications associated with the uses of these devices include death, stroke, acute kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.

The transcatheter heart valves should not be used in patients who cannot tolerate blood-thinning medications or have an active infection in the heart or elsewhere. Additionally, the CoreValve Evolut R and CoreValve Evolut PRO devices should not be used in patients who have sensitivity to titanium or nickel. Furthermore, the long-term durability of transcatheter heart valves compared to surgically implanted valves has not been established. Patients, especially younger ones, should discuss available treatment options with their heart care team to select the therapy that best meets their expectations and lifestyle.

These devices were approved using the Premarket Approval (PMA) pathway. Premarket approval is the most stringent type of device marketing application required by the FDA and is based on a determination by the FDA that the PMA application contains sufficient valid scientific evidence to provide reasonable assurance that the device is safe and effective for its intended use(s).

As part of the approval of these devices, the FDA is requiring each manufacturer to continue to follow patients enrolled in their randomized studies for 10 years to further monitor transcatheter aortic valve safety and effectiveness, including the long-term valve durability. The manufacturers will also participate in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry to provide FDA with additional surveillance of these devices over a 10-year period.

The approval of the Sapien 3 and Sapien 3 Ultra was granted to Edwards Lifesciences LLC. The approval of the CoreValve Evolut R and CoreValve Evolut PRO was granted to Medtronic CoreValve LLC.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.