People with heart failure are at risk of developing significant secondary MR, a serious and progressive heart disease in which the two chambers of the left side of the heart become enlarged, thus preventing the mitral leaflets from closing normally and allowing blood to flow backwards through the heart. This can lead to reduced quality of life, recurrent hospitalizations and decreased survival.3,4,5 Most heart failure patients with clinically significant secondary MR are treated with medication only, but data shows that these patients can benefit from reduction in MR with MitraClip.

"Approximately four million Americans suffer from MR, and it's estimated that two to three times as many patients may benefit from MitraClip for secondary mitral regurgitation than those for the primary form of the disease," said Michael Dale, senior vice president of Abbott's structural heart business. "We've worked tirelessly, for nearly two decades, to make MitraClip's leading technology available to patients suffering from mitral regurgitation, and CMS' expanded coverage allows our safe, effective and potentially life-saving treatment option to be available to the many more people who could benefit from our minimally invasive therapy."

This NCD revision is critically important to secondary MR patients, as most of those impacted by MR are older – with one in 10 adults age 75 or older experiencing MR6 – and therefore relying on Medicare for their health insurance. Medicare coverage is limited to treatments, procedures and other healthcare items or services that CMS considers reasonable and necessary. National Coverage Determinations mandate coverage at the national level for all Medicare beneficiaries, including those participating in Medicare Advantage plans. Had CMS not revised the NCD to include the new secondary MR indication, Medicare patients with the secondary form of the disease would have continued to be ineligible for coverage and required to pay out of pocket for the procedure – creating a barrier to therapy access for patients.

About the MitraClip System
MitraClip is the world's first TEER (TMVr) therapy with more than 17 years of clinical experience and proven safety, survival and durable clinical outcomes. The device is approved in more than 75 countries worldwide, spanning regions in Asia, Africa, Europe, the Americas and Australia.

MitraClip is a small, clip-based device that repairs both primary and secondary MR without the need for open-heart surgery. The device is delivered to the heart through a vein in the leg and works by clipping together a portion of the leaflets of the mitral valve to reduce the backflow of blood, allowing the heart to pump blood more efficiently.

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