FDA expands indication for several transcatheter heart valves

FDA expands indication for several transcatheter heart valves

Press releases may be edited for formatting or style | August 19, 2019 Cardiology Operating Room

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.

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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 U.S. 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.

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