The FDA Sends Abbot Back to the Drawing Board

StethoscopeIt is no easy task developing a revolutionary medical procedure.

Abbott Laboratories (NYSE:ABT) has described its Mitraclip heart device as a “true advance” for inoperable patients suffering from mitral regurgitation, a condition in which the valve between the heart’s two left chambers does not fully close, forcing the heart to work harder and increasing the risk of heart failure.

But the Food and Drug Administration is less convinced; on Monday, the agency recommended against approval of the device. When explaining its decision, the FDA stated that there was not enough evidence to show that the product is safe and effective, according to The Wall Street Journal.

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The pharmaceutical company is seeking FDA approval of the heart device that was designed to fix leaky heart valves in patients who are not considered good candidates for valve-replacement surgery. Mitraclip – a device already sold in 30 countries outside the United States — was developed to be introduced to the body through a small incision in the leg, after which it is deployed to pin together the leak.

Many patients whose risk factors for mitral-valve surgery are too high have limited options to treat their condition, Abbott has argued, making the company’s device a significant expansion of the available treatments for the condition. “The MitraClip device represents a true advance for these patients, and we look forward to discussing the totality of the clinical evidence with the advisory committee members and hearing their recommendations on Wednesday,” the company said in a statement seen by the publication.

While the FDA released a staff review of Mitraclip on Monday, Abbott’s application will be given further consideration by an advisory committee consisting of non-FDA medical experts on Wednesday. They will be asked to discuss the clinical data and then vote on whether Mitraclip should be approved. The agency is not required to adhere to the panel’s decision, though it does typically follow it.

As for its own opinion, the FDA found that data from the clinical trial submitted by Abbott was “difficult to interpret,” according to the Journal. Data showed that the study, comparing the Mitraclip procedure to the valve-replacement surgery, met its safety goals but did not meet a required effectiveness measure. A second data set examined how effectively the device treated “high-risk” patients as compared to those patients who had received nonsurgical treatments. These numbers also were not enough to convince the FDA that the device should be approved.

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Despite its negative recommendation, the agency did note that the device should remain available as an investigation device so that it can be used in two other clinical trials that are studying “high-risk” inoperable patients.

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