FDA Warns Against Approval of MitraClip Heart Device By Tod Aronovitz | 03/19/13 | 0 Comment

The MitraClip heart device should not be approved by the Food and Drug Administration, according to an FDA staff review released on Monday.

Claiming there is not enough evidence to show the product is safe and effective, the agency released an FDA Executive Summary on the Abbott Vascular MitraClip Clip Delivery System in advance of a March 20, 2013 meeting of the Circulatory System Devices Panel. The panel will review a request for Premarket Approval (“PMA”) filed by manufacturer Abbott Laboratories.

The MitraClip medical device is intended for use on high risk inoperable and high risk mitral valve patients. It is delivered to the heart through the femoral vein, a blood vessel in the leg, and is designed to reduce mitral regurgitation (“MR”) by allowing the heart to pump blood more efficiently.

Noting that the PMA research results are “interesting and important,” the FDA recommends that additional studies are needed. The FDA is working with the sponsor to develop a new U.S. randomized controlled trial for the device, and continues to monitor European studies.

Abbott’s MitraClip system is commercially available in approximately 30 countries. Over 8,000 patients have been treated to date.

Mitral regurgitation is the most common type of heart valve insufficiency, affecting approximately 10 percent of people aged 75 years and older. Patients with the heart disease experience failure of the mitral valve. Stress put on the heart in MR can result in irregular heartbeats, stroke, heart attack or death.

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