When a person's heart failure leads to a leaky mitral valve, also known as secondary (or functional) mitral regurgitation (MR), historically there hasn't been much doctors could do.
But now, the U.S. Centers for Medicare & Medicaid Services (CMS) has expanded coverage for Abbott's market-leading MitraClip™ device to people with secondary MR resulting from heart failure.
Here's what this means: There will be a significant increase in the number of Americans eligible for insurance coverage for mitral valve repair with MitraClip enabling broader access to the life-changing tech.
Consider that approximately 4 million Americans have MR, a serious and progressive heart disease, in which the heart's mitral valve doesn't close tightly, allowing blood to flow backward through the heart.
In 2019, 2-3 times more Americans got access to MitraClip when the U.S. Food and Drug Administration expanded the indication for the device beyond primary (or degenerative) MR (usually due to an abnormality of the mitral valve) to secondary MR.
Now, expanded Medicare reimbursement enables many more of these patients to actually receive treatment. Without this reimbursement, people with Medicare would have to pay out of pocket for the procedure.
"Secondary mitral regurgitation generally impacts older individuals suffering from heart failure who rely on Medicare for their healthcare coverage," said Neil Moat, M.D., chief medical officer of Abbott's structural heart business. CMS' decision to expand coverage for MitraClip marks a pivotal moment for people seeking a minimally invasive option that reduces mitral regurgitation and significantly improves their quality of life and chances of survival."
MitraClip's Growing Market
The transcatheter clip-based therapy, available in the U.S. since 2013, has been used to treat more than 100,000 people worldwide for over 16 years.1
That number could grow significantly both from CMS' decision and the world's aging population, possibly creating greater need for innovative heart treatments.
By 2050, 1 in 6 people in the world will be over age 65 (16%), up from 1 in 11 (9%) in 2019, according to data from the United Nations' 2019 Revision of World Population Prospects.2
Abbott's $1.4 billion in 2019 structural heart sales — which includes MitraClip— highlights the company's strength in the market as well as its potential to expand.
Expected to help sustain this momentum is MitraClip, a first-of-its-kind device that's available in more than 75 countries and on a fourth generation of product innovations.
"MitraClip has become a standard of care for the treatment of mitral regurgitation around the world, providing patients and physicians with a treatment option that was barely imaginable in the recent past – and one with an improved benefit-risk profile for patients," said Michael Dale, senior vice president of Abbott's structural heart business. "This expanded coverage from CMS underscores the need for MitraClip's innovative therapy and expands our mission to help people live better lives through better health."
Learn more about Abbott's MitraClip and its other game-changing heart tech.
U.S. important safety information on MitraClip™.
1Data on file at Abbott
2United Nations' 2019 Revision of World Population Prospects.