The FDA released documents about the device, called Watchman, ahead of a meeting on Wednesday of outside medical experts who will consider its risks and benefits and then recommend whether the FDA should approve the product for use in patients. An FDA advisory panel in 2009 recommended approval of the first-of-its-kind device, but the agency ultimately decided another study was needed to evaluate its safety and effectiveness. FDA staff on Monday said the expert panel will need to consider follow-up results from the first trial, data from a patient registry and the new study results in making its recommendations. Wells Fargo analyst Larry Biegelsen said he believes the FDA will approve the device, but cautioned that Wednesday's meeting could be contentious.
Source: FOX NEWS
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