FDA Approves New Indication For MitraClip to Repair MR

The U.S. Food and Drug Administration (FDA) on March 14 approved the MitraClip Clip Delivery System to repair mitral regurgitation (MR). The transcatheter clip-based therapy, used to repair a leaky mitral valve without open-heart surgery, has been used with more than 65,000 patients worldwide over the past 10 years.

The expanded approval is for treatment of patients with normal mitral valves who develop heart failure (HF) and moderate-to-severe or severe MR despite receiving optimal treatment, including HF medications or, for certain patients, cardiac resynchronization therapy or ICD implantation. The approval is based on a study that found patients with HF and MR who received MitraClip vs. medication only had a 47 percent reduced risk of HF hospitalization and a 37 percent decreased risk of mortality within two years.

Clinical Topics: Arrhythmias and Clinical EP, Cardiac Surgery, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Implantable Devices, Cardiac Surgery and Arrhythmias, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Structural Heart Disease, Mitral Regurgitation

Keywords: Mitral Valve Insufficiency, Mitral Valve, Cardiac Resynchronization Therapy, United States Food and Drug Administration, Heart Failure, Cardiac Surgical Procedures, Hospitalization, Surgical Instruments

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