Expectations of FDA approval of Abbott's novel non-invasive mitral regurgitation repair device were low, given that in March a staff review of the application recommended that the agency reject it.
But on Friday Abbott announced that the federal agency approved its MitralClip system, and the product would launch immediately in the U.S. Analysts found the news surprising yet well-timed given a major interventional vascular conference - Transcatheter Cardiovascular Therapeutics - is set to be underway in San Francisco on Sunday.
“We expect ABT to launch a big marketing campaign at the Transcatheter Cardiovascular Therapeutics (TCT) conference,” wrote Glenn Novarro, senior analyst at RBC Capital Markets, in a research note Friday.
He added that revenue from the sale of the product will be minimal this year - around $5 million - but MitralClip could “turn into a $500M+ revenue opportunity in the U.S.”
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Mitral regurgitation occurs when the mitral valve doesn’t close tightly enough such that blood flows backward into the heart and not out to the rest of the body. Abbott's MitraClip involves implanting a device percutaneously using a steerable guide catheter and a clip delivery system.
It has been specifically approved in patients with significant symptomatic degenerative MR who are too sick to undertake the risk of open-heart surgery.
Another analyst also echoed Novarro’s surprise at the news of approval. But Danielle Antalffy of Leerink Swann said the rollout of the product will be gradual since reimbursement rates are low. In her research note Friday, she says current reimbursement is about $17,000 for a device that costs $30,000. She added that initial target population will be 350,000 who are considered to be at high risk for open heart surgery.
"MitraClip is a breakthrough in the treatment of severe mitral regurgitation, a condition that is progressive and causes extreme fatigue and shortness of breath, eventually making even simple tasks virtually impossible, and increasing the risk of stroke, heart failure and death," said Dr. Ted Feldman, director, Cardiac Catheterization Laboratory and The Mr. and Mrs. Charles R. Walgreen Chair in Interventional Cardiology, NorthShore University HealthSystem, Evanston, Ill, in an Abbott news release. "Clinical data and real-world international experience, dating back to 2003, have consistently shown that the MitraClip is a safe and effective therapy for patients unable to undergo mitral valve surgery, providing meaningful improvements in quality of life that are sustained over time. It has allowed many of my patients to go from bed rest to a more active lifestyle shortly following treatment."
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