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SEDASYS System Reduced Risk Of Over Sedation With Propofol

Armen Hareyan's picture

Ethicon Endo-Surgery's pivotal trial demonstrated physician/nurse teams using the SEDASYS System reduced the risk of over sedation with propofol in patients undergoing screening and diagnostic procedures for colorectal cancer (colonoscopy), and disorders of the upper gastrointestinal tract (EGD). The study -- which will be presented Tuesday at Digestive Disease Week(i) -- included 1,000 subjects who underwent sedation for colonoscopy and EGD at eight sites and compared the SEDASYS System to the current standard of care for sedation (midazolam plus fentanyl or meperidine). Results were included in Ethicon Endo-Surgery's PreMarket Application (PMA) for approval of the SEDASYS System, which is currently in review with the U.S. Food and Drug Administration.