The U.S. Food and Drug Administration (FDA) approved the MitraClip® System, a novel device designed to repair leaky valves in patients with degenerative mitral regurgitation. The FDA followed the recommendation of the Circulatory System Devices Panel of the Medical Devices Advisory Committee, which voted earlier this year in favor of approving the device for use in patients who are considered too high risk for open mitral valve surgery.

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During the advisory panel meeting, experts representing the ACC and The Society of Thoracic Surgeons (STS) provided valuable guidance for the panel to take into account during its decision making. In recent years, the ACC and STS have forged a partnership to provide professional leadership, patient advocacy, and guidance to the government during the current era of novel technology development and dispersion in the field of transcatheter valve therapy.

In representing the ACC and STS, John Carroll, MD, FACC, and Fred Edwards, MD, FACC, underscored the importance of appropriate patient selection and heart team collaboration in treating this inoperable patient population. They also addressed the role registries play in post-market surveillance.

"This was a unique panel with two schools of thought emerging," said Carroll after the hearing. "On one hand, there was much discussion surrounding the importance of clinical judgment, access to new treatments for inoperable patients, and potential acceptability of solid and consistent observational data with imperfect comparators. On the other, there was concern regarding the lack of strong, well-executed randomized trial data of the target patient population. The patient testimonials were compelling and in line with the data showing enhanced quality of life."

Abbott's central argument was that the device represents a treatment option for patients with no alternatives at present. According to Patrick McCarthy, MD, FACC, who spoke on behalf of Abbott, "all surgeons and cardiologists" want options for treating patients with severe mitral regurgitation. In the end, the panel expressed concerns about appropriate patient population and effectiveness data, but was convinced about safety and found the benefits to outweigh the risks.

Keywords: Cooperative Behavior, Registries, Patient Selection, United States Food and Drug Administration, Decision Making, Quality of Life, Mitral Valve Insufficiency, Patient Advocacy, Advisory Committees

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