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January 13, 2020

FDA Approves REPAIR MR Trial for Abbott's MitraClip in Patients at Moderate Surgical Risk

January 13, 2020—Abbott announced that the FDA has approved a clinical trial that will compare the effectiveness of the company’s transcatheter MitraClip device to mitral valve surgical repair in patients with primary mitral regurgitation (MR) who are eligible for open heart surgery.

The prospective, randomized REPAIR MR clinical trial will enroll approximately 500 patients at 60 sites in the United States, Canada, and Europe to evaluate the effectiveness of the MitraClip device in patients at moderate surgical risk with severe primary MR who are candidates for open heart surgery.

If successful, the trial has the potential to expand treatment options for patients with mitral valve disease, whose current options are limited to open heart surgery, by expanding MitraClip’s current indication (patients at prohibitive risk for surgery) to also include patients at moderate risk. The MitraClip system, now on its fourth-generation device, has been commercially available in the United States since 2013 and in Europe since 2008.

According to Abbott, the trial’s design addresses the issue that despite symptoms and increased mortality, patients with MR are often undertreated by open heart mitral valve surgery. Currently, only an estimated 15% of patients who are eligible for the standard-of-care surgery for their primary MR undergo surgical treatment. In some cases, this may be because the MR goes undiagnosed, but in others, patients may forgo surgery because of prolonged recovery time or fear of possible surgical complications.

The REPAIR MR trial will be led by Coprincipal Investigators Patrick McCarthy, MD, and Saibal Kar, MD. Dr. McCarthy is Chief of Cardiac Surgery, Northwestern Medicine, and Executive Director, Bluhm Cardiovascular Institute in Chicago, Illinois. Dr. Kar is Director of Structural Heart Disease and Research, Los Robles Hospital and Medical Center in Thousand Oaks, California.

In the company’s announcement, Dr. McCarthy commented, "The REPAIR MR trial seeks to evaluate the MitraClip device in treating a new patient population who currently undergo the standard surgical treatment but are at moderate surgical risk. This is an important question since approximately 70% of people diagnosed with primary mitral regurgitation aren’t treated with open heart mitral valve surgery today yet are in need of treatment and symptom relief."

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