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| MitraClip cardiac device--Courtesy of Abbott |
Abbott ($ABT) may not have to look too far for a big win after the Centers for Medicare & Medicaid Services (CMS) proposed coverage for its MitraClip, currently the only FDA-approved device for transcatheter mitral valve repair or replacement.
The CMS issued a draft National Coverage Decision last week, which if approved, would green-light patients with significant degenerative mitral regurgitation to have surgery to fix or replace leaky heart valves using the MitraClip. The device is delivered by a catheter inserted through the femoral vein in the leg, and then clips together parts of the mitral valve in a procedure that is less invasive than regular surgery.
"This national coverage proposal represents an important step in improving access to Abbott's MitraClip device for very sick patients, who often have no other treatment options," Chuck Simonton, chief medical officer of Abbott Vascular, said in a statement. "We commend the extensive, collaborative efforts between CMS, FDA and medical societies in supporting this process so that patients can benefit from this innovative therapy that could significantly improve the quality of life for these people."
It's been a long trip to market for the MitraClip. Abbott won FDA approval for the device last October after months of setbacks, including an overseas safety warning, mixed study results and a cautious endorsement from a regulatory panel of experts concerned over MitraClip's effectiveness.
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