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Pivotal Study Shows Physician/Nurse Teams Using SEDASYS(TM) System Reduced Risk of Over Sedation With Propofol
Date:5/19/2008

d an average AUC value of one-third less than the current standard of care patients. No device-related adverse events occurred in patients sedated with the SEDASYS(TM) System.

SEDASYS(TM) System patients were minimally-to-moderately sedated with propofol during the study. Sedation level was assessed every two minutes using a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale of 0-5. Patients who are minimally sedated respond readily when called by name (MOAA/S=5), while moderately sedated patients may require mild tactile stimulus to respond (MOAA/S=2-4). More than 99 percent of SEDASYS(TM) System patient responses were a MOAA/S score of 2 -- 5, indicating minimal to moderate sedation.

Minimal to moderate propofol sedation with the SEDASYS(TM) System provided patients a faster recovery from sedation than current standard of care. Patients recovered from sedation almost two times faster with the SEDASYS(TM) System and approximately 99 percent of SEDASYS(TM) System patients recovered within 10 minutes. Patient recovery time was measured from scope removal to the time the patient returned to a MOAA/S=5.

Colonoscopy is considered the gold standard for detecting colorectal cancer, the second-leading cause of cancer-related deaths in the United States. The American Cancer Society is calling for increased colorectal cancer screening and recommends that people aged 50 and older receive regular screenings.(ii)

"Patients understand that recovery from sedation takes time after a colonoscopy, but with propofol, they recuperate quicker and are functional sooner," said Dr. Pambianco. "GIs have been performing procedures with current standard of care sedatives for years and maintaining a constant sedation level in patients can be daunting. The novelty of this system is that it has the potential to accurately tune into my patient's sedation needs by following their vital signs and delivering propofol in a precise manner."

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SOURCE Ethicon Endo-Surgery
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