Panel Gives Lukewarm Response for Abbott's MitraClip

Abbott-MitraClipThere have been reports of a lukewarm response from the FDA’s Circulatory System Devices advisory panel regarding the endorsement of Abbott Laboratories’ MitraClip device.

The panel met to analyze the benefits of the device to the patients with main symptomatic mitral regurgitation (MR). The reported observations were witnessed and endorsed by a cardiac surgeon.  After the meeting, the panel voted 5-3 in favor of the device. The ones who supported stated that the benefits outnumbered the risks.

The decision by the panel was supported by everyone present. They agreed that the device was safe (8-0) but only involved a risk by a thin margin (5-4). One aspect that the panel found important to understand was to categorize the set of people who could benefit from the device.

After getting convinced by the pleas of surgeons and patients, panel agreed to provide the green signal, though with a thin majority. The FDA reviewers had earlier suggested the disapproval of the device.

The discussion involved two opinions. One of them was positive for the drug. It included clinical judgment that examined new treatments for untreatable patients.

Another school of thought included the dilemma over the dearth of strong, well-executed randomized trial data of the target patient population.

Eventually, the testimonials from patients were coincident with the data shown by the physicians.