On March 20, the U.S. Food and Drug Administration (FDA's) Circulatory System Devices Panel of the Medical Devices Advisory Committee convened to examine Abbott Vascular Inc. 's pre-market approval application for the MitraClip® System and its use in patients who are considered too high risk for open mitral valve surgery. After listening to numerous accounts from experts, patients and Abbott during the day-long hearing, the advisory panel, that included five surgeons and five cardiologists, voted in favor of approval. The decision now heads to the FDA.
|The ACC and The Society of Thoracic Surgeons (STS) were each represented in front of the panel by experts who 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. View lists of the discussion questions and voting questions that were addressed during the meeting.
Ahead of the advisory panel meeting, the ACC and STS submitted joint comments that detailed addressing mitral regurgitation and the landscape for new treatments; how members of the societies are involved in the care for these patients; how each organization is providing leadership, clinical guidance and education/training related to transcatheter therapies for valvular heart disease; and the potential role of the STS-ACC TVT Registry™ with the MitraClip System.
The MitraClip is a tiny device threaded through an artery to repair leaky heart valves in select patients with mitral regurgitation. The MitraClip System includes the delivery catheter, the steerable sleeve, and the MitraClip device. Results from the EVEREST II study — presented during ACC's 2011 Scientific Session — showed that the MitraClip compares favorably with conventional open-heart surgery for treatment of select patients with mitral regurgitation. The device is currently on the market in more than 40 countries.