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Abbott announced on Monday that the FDA has approved a "first-of-its-kind" clinical trial that will compare the effectiveness of the company's MitraClip device to open-heart mitral valve surgical repair in patients with primary mitral regurgitation who are eligible for open-heart surgery. If successful, the REPAIR MR study has potential to expand the device's current indication, for use in patients at prohibitive risk for surgery, to also include patients at moderate risk.
Co-principal investigator Patrick McCarthy noted that the study "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." He added that "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."
REPAIR MR will enrol around 500 patients to evaluate the effectiveness of the MitraClip device in moderate-surgical-risk patients with severe primary mitral regurgitation who are candidates for open-heart surgery, which is the current standard of care.
MitraClip was initially approved in the US in 2013 for patients with primary mitral regurgitation at prohibitive risk for mitral valve surgery, with a fourth-generation version of the device approved last July. US regulators last year also expanded MitraClip's indication to include patients with severe secondary mitral regurgitation.
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