Amid FDA app, Abbott hits safety snag with MitraClip

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Abbott Laboratories issued a safety warning for its MitraClip device.--Courtesy of Abbott Laboratories

Abbott Laboratories ($ABT) is in the throes of the FDA approval process for MitraClip here in the states, but overseas, the company issued a safety warning over the cardiac device.

Last month, Abbott informed its customers in the U.K. and elsewhere that turning MitraClip's knob the wrong way could result in patient injury, pointing to three such reports since 2008, Dow Jones reports. One patient died after an emergency revision surgery related to the device, the news agency notes.

Abbott is reminding surgeons to make sure to turn MitraClip's knob counter-clockwise, and the company has added an arrow to the device in an effort to prevent future mistakes, the company said. The next generation of the device will make improper turning impossible, Abbott said.

A company spokesman told Dow Jones that Abbott doesn't expect the overseas warning to affect its ongoing discussions with the FDA. Last week, the agency's Circulatory System Devices Panel voted 5-3 to recommend MitraClip for approval, but the group unanimously found the device to be safe.

Abbott is facing something of an uphill battle with MitraClip, its first big regulatory foray since splitting in two back in January. While the panel eventually sided with the device, the FDA has voiced concerns that Abbott's supporting data doesn't adequately demonstrate MitraClip's benefits versus risks for patients with poor heart function due to mitral regurgitation.

Earlier this month, agency staff recommended Abbott amass more data before getting approval, which, if the broader FDA agrees, could add years to MitraClip's marketing timeline.

- read the Dow Jones story
- check out Abbott's warning (PDF)

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