FDA Approves Next-Generation MitraClip System

The U.S. Food and Drug Administration recently granted approval to Abbott Structural Heart for a third-generation version of the company's MitraClip® system for transcatheter-based mitral valve repair. The transcatheter clip-based therapy, used to repair a leaky mitral valve without open-heart surgery, has been employed in the treatment of more than 65,000 patients worldwide over the last ten years.

Abbott recently began enrollment for a prospective study evaluating the safety and performance of the new MitraClip system in a contemporary real-world setting. The MitraClip EXPAND clinical study will enroll a real-world cohort of approximately 1,000 patients with interim results expected later this year.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention

Keywords: ACC Advocacy, Mitral Valve, United States Food and Drug Administration, Cardiac Surgical Procedures


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