Abbott Labs Gets FDA Approval for MitraClip for Leaky Heart Valves

By Chris Wack

Abbott Laboratories (ABT) has received approval from the Food and Drug Administration for a next-generation version of its leading MitraClip heart valve repair device used to repair a leaky mitral valve without open-heart surgery.

The Abbott Park, Ill.-based company said in a release Thursday that it received CE Mark for the next-generation device earlier this year, allowing for sale of the devices in the European Union and other countries that recognize the regulatory designation.

The next-generation MitraClip system provides cardiologists with advanced steering, navigation and positioning capabilities for the clip, making it easier to use in difficult anatomies, Abbott said.

Abbott recently began enrollment in the MitraClip EXPAND clinical study, a prospective study evaluating the safety and performance of the new MitraClip system in a contemporary real-world setting.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

July 12, 2018 09:37 ET (13:37 GMT)

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