Abbott Laboratories is celebrating an announcement from the U.S. Food and Drug Administration that greatly expands the potential market for one of the company’s most promising heart devices -- a $25,000 minimally invasive device used to treat mitral regurgitation.
Illinois-based Abbott, which employs thousands of people in Minnesota, announced this week that the FDA has approved its MitraClip device to treat people in whom enlargement of the heart from heart failure warps the mitral valve, allowing blood to flow backward in the heart.
Known as “secondary” or “functional” mitral regurgitation, this condition is about three times more common than the first MitraClip indication, approved in 2013, for the treatment of structural defects in the mitral valve leaflets themselves.
The FDA approved MitraClip for secondary mitral regurgitation after a widely noted clinical trial known as COAPT found that in a randomized population of 614 people, patients who got the device had a 38 percent relative reduction in all-cause mortality after two years, compared to the control arm. About 29 percent of the MitraClip patients died, compared to 46 percent who got traditional treatment.
About 4 million Americans have one of the forms of mitral regurgitation, including 1 in 10 people aged 75 or older. “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,” Abbott said in its announcement.
MitraClip is a minimally invasive device that attaches to the mitral leaflets without open-heart surgery. Rather than a chest incision, the devices is inserted through a puncture in the leg and advanced into position through the blood vessels.
Analysts with J.P. Morgan said Abbott gets about $25,000 for each MitraClip, and each procedure uses an average of 1.5 devices. That means each 1,000 new procedures equate to about $37.5 million in revenue.
Stock analysts with Bernstein estimated that Abbott took in about $500 million from MitraClip sales under the narrower indication in 2018, and that sales of the device could climb to as much as $2 billion a year within 5 years.