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| Abbott's MitraClip cardiac device won FDA approval.--Courtesy of Abbott |
Abbott ($ABT) finally won FDA approval for its MitraClip cardiac device after months of setbacks including an overseas safety warning, mixed study results and a cautious endorsement from a regulatory panel of experts worried about the product's effectiveness.
MitraClip can now be used in the U.S. for patients who have significant degenerative mitral regurgitation who face too big of a risk with mitral valve surgery. Mitral regurgitation involves a leaky heart valve that lets blood flow backward and can cause irregular heartbeats, stroke or heart failure. MitraClip is delivered via catheter through the femoral vein in the leg, and it clips together parts of the mitral valve. The solution is meant to be less invasive than regular surgery.
In announcing the long-awaited approval, Abbott cited the fact that more than 11,000 patients in over 30 countries have been treated with the device. The company also noted that it has clinical data backing its safe use dating back to 2003. Meanwhile, two separate clinical trials in the U.S. and Europe continue to test the device as a treatment for heart failure.
MitraClip's road to approval in the U.S. was often rough. In June, Abbott highlighted the positive by touting European study results that found MitraClip was both safe and effective as a treatment for mitral regurgitation. In May, a four-year follow-up look at the company's pivotal EVEREST II trial concluded that patients with MitraClip needed additional operations and that its benefits were no different from those of traditional mitral valve surgery.
Earlier this year, Abbott issued a safety warning to patients in the U.K. and elsewhere noting that turning MitraClip's knob the wrong way could injure patients. And the FDA Circulatory System Devices Panel in March gave the product a mixed endorsement, particularly regarding whether the device is effective.
John Capek, Abbott's head of medical devices, told Bloomberg that the company's initial U.S. market for the product is about 20,000 or 30,000 patients, about 1/10th of mitral regurgitation patients at risk for surgery in the country.
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- here's Bloomberg's take