The decision significantly increases the number of people eligible for insurance coverage for mitral valve repair with MitraClip, enabling broader access to the device. As the first and only TEER device approved by the
'Secondary mitral regurgitation generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage,' said
Following MitraClip's original approval by the FDA in late 2013, CMS provided coverage for Medicare patients with primary (degenerative) mitral regurgitation who needed treatment with MitraClip. Similarly, this revised NCD comes after the
Supported by more than 17 years of clinical trial data demonstrating safety and efficacy, and now on the fourth generation of product innovations, MitraClip is a first-of-its-kind device that clips together the leaflets, or flaps, of the mitral valve to reduce the backflow of blood and restore the heart's ability to pump oxygenated blood efficiently. The device provides symptom relief for both primary and secondary MR, with most patients being released from the hospital, on average, two days post-procedure.2
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
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
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.
The MitraClip system has been commercially available in
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