The Food and Drug Administration has reconsidered its denial of Ethicon Endo-Surgery Inc.’s application to begin selling a computer-assisted sedation system.
The move provides an opening for the Cincinnati-based surgical products company to commercialize its Sedasys system, though the FDA still needs to approve Ethicon’s application before that can happen. The system couples physiological patient monitoring with personalized drug delivery, and could help reduce risks associated with sedation, according to Ethicon.
A new independent FDA advisory panel will be appointed to vote on Ethicon’s Premarket Approval Application (PMA), though its vote isn’t binding, which Ethicon knows all too well.
A previous advisory committee already voted in favor of the application. The key word is “advisory.” If the FDA approves the application, the company would be free to begin selling the Sedasys in the United States.
The FDA denied the system due to objections to the company’s proposed labeling for the device. The labeling would allow gastroenterologist and nurse teams to administer the sedative drug propofol without an anesthesia professional present.
The Sedasys system has received regulatory approval for sale in the European Union, Australia and Canada, according to the company.
