FDA Approves Low-Risk Indication for TAVR

August 16, 2019—The FDA announced it has approved an expanded indication for transcatheter aortic valve replacement devices to include patients with severe aortic valve stenosis who are at low risk for death or major complications associated with open heart surgery to replace the damaged valves.

The specific TAVR devices—Sapien 3 and Sapien 3 Ultra (Edwards Lifesciences); CoreValve Evolut R and CoreValve Evolut Pro (Medtronic)—were previously indicated only for patients at intermediate or higher risk for death or major complications during open heart surgery.

According to the FDA, it 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.

The FDA advised that 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.

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 device 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.

Bram Zuckerman, MD, Director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health, stated in the announcement, “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. 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.”

• Edwards' Sapien 3 TAVR Systems Receive FDA Approval for Low-Risk Patients
• FDA Approves Low-Risk Indication for Medtronic's Evolut TAVR System

Steven J. Yakubov, MD, discussed the FDA approval of the low-risk indication for TAVR with Cardiac Interventions Today. Dr. Yakubov is System Chief, Advanced Structural Heart Disease at OhioHealth Research Institute, Riverside Methodist Hospital in Columbus, Ohio. Dr. Yakubov commented to Cardiac Interventions Today: