By an 11 to 5 margin, an FDA advisory panel voted that the benefits of St. Jude Medical’s Amplatzer PFO occluder device outweighs its risks, the Minneapolis Star Tribune reports.
The same panel voted 15-1 in favor of the device’s safety and 9-7 in favor of its efficacy. If approved, the device could account for between $200 million and $350 million in sales, according to the newspaper.
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Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.