Abbott ($ABT) is promoting positive data from a pivotal trial for its mitral regurgitation treatment device, showing that the product helped patients otherwise at high risk for surgery. Expect executives to use the results to make their case for FDA approval during a March 20 Advisory Committee meeting.
The product--Abbott's MitraClip System--has long had a CE mark, is available in 30 countries and has treated 8,000 patients to date. But all of that is outside the U.S., which is a crucial market that many device companies avoid at first because the approval process can take longer. Abbott's strategy can also be beneficial, though, because getting a device approved in other countries allows it time to generate revenue and product-use data in advance of the FDA's at-times lengthy and demanding regulatory approval process.
Abbott's good news about MitraClip comes from its EVEREST II trial, and the company shared details at the American College of Cardiology annual meeting in San Francisco. EVEREST II tested 351 patients with mitral regurgitation who were deemed too risky for the usual course of treatment--open mitral valve surgery. Researchers found that the 30 day mortality rate for MitraClip was much lower than surgery (4.8% compared to 18.2%). Additionally, the surgery carried a 96% implant success rate and a low rate of adverse events. MitraClip is implanted percutaneously through a blood vessel in the leg and clips mitral valve "leaflets" together to help the heart work more efficiently.
Crucially, patients also saw major improvements in quality of life, which included "clinically significant improvement" in their left ventricular size and lower heart failure hospitalization rates a year after discharge versus the year before treatment.
Abbott says the increased body of data from MitraClip work shows it can make a difference in patients at high risk for surgery. And the company plans to aggressively make its case before an FDA panel of experts on March 20. That group's final recommendation isn't binding, but the FDA usually follows the panel's final word.
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