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Abbott : FDA Oks MitraClip Device To Treat People With Leaky Heart Valves

Abbott (ABT) said it received approval from the U.S. Food and Drug Administration for a next-generation version of its MitraClip heart valve repair device used to repair a leaky mitral valve without open-heart surgery. The transcatheter clip-based therapy, now on a third generation of product innovations, has been used to treat more than 65,000 patients worldwide over the last ten years.

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. The enhanced system is designed to allow for more precise placement during deployment, resulting in more predictable procedures, and additionally offers a second clip size with longer arms that expands the reach of the clip-based device.

The additional clip size is designed to help doctors treat patients who have morecomplex anatomies when repairing the mitral valve.

Abbott noted that it 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.

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