Research & Development
Abbott wins US FDA approval for new, expanded indication for MitraClip device to address the secondary form of MR
15 March 2019 -

Healthcare company Abbott (NYSE:ABT) revealed on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for the new, expanded indication for its leading MitraClip device for secondary, or functional, mitral regurgitation (MR) without open-heart surgery.

Based on the results of the COAPT (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial, the company investigated MitraClip for treating secondary MR and the data add to ten years of evidence on the use of MitraClip for treating both primary and secondary MR. COAPT met both primary and secondary endpoints, showing a relative 47% reduction in hospitalisations and a 38% reduction in mortality.

The company said MitraClip transcatheter clip-based therapy, which available in the US since 2013 and now on a third generation of product innovations, has been used to treat more than 80,000 patients worldwide over the last ten years. The new, expanded indication now addresses the secondary form of MR.

According to the company, the MitraClip device repairs MR without open-heart surgery and is delivered to the heart through a small incision in the leg. The device clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood, restoring the heart's ability to pump oxygenated blood more efficiently.

Following the US FDA approval, the company will begin discussions with the Center for Medicare and Medicaid Services (CMS) and physician specialty societies to request a revision to the national coverage determination (NCD) that would expand Medicare coverage to include secondary MR patients.

Significant secondary MR can lead to reduced quality of life, recurrent hospitalisations and decreased survival. Medication alone is the current standard of care for most heart failure patients with secondary MR, but this approach only helps manage the symptoms and does not address the underlying cause.



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