March 21st, 2013

FDA Panel Gives Tepid Endorsement to Abbott’s MitraClip

The FDA’s Circulatory System Devices advisory panel gave a tepid endorsement to Abbott Laboratories’ MitraClip device on Wednesday. The panel met to evaluate use of the novel device in patients with significant symptomatic mitral regurgitation (MR) who  have been determined by a cardiac surgeon to be too high risk for open mitral valve surgery and in whom existing comorbidities would not preclude the expected benefit from correcting the MR.

MitraclipAt the end of the day, after a long and torturous discussion, the panel voted 5-3 in favor of the device, saying that the benefits outweighed the risks. The panel agreed unanimously that the device was safe (8-0), but by a narrow margin said there was not a “reasonable assurance” that it was effective (5-4). The panel struggled over how to use the available data to identify patient groups that could benefit from the device.

In the end, many panel members appeared to be persuaded by the pleas of surgeons and patients asking for another option in the most difficult cases. Earlier in the week the FDA reviewers had recommended against approving the device.

“This was a unique panel with two schools of thought emerging, ” said John Carroll on Cardiosource. “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. ”

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