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

Tuesday, May 20, 2008 General News
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SAN DIEGO, May 19 DDW 2008 Annual Meeting -- EthiconEndo-Surgery announced today that the results from its pivotal trialdemonstrated physician/nurse teams using the SEDASYS(TM) System reduced therisk of over sedation with propofol in patients undergoing screening anddiagnostic procedures for colorectal cancer (colonoscopy), and disorders ofthe upper gastrointestinal tract (EGD). The study -- which will be presentedTuesday at Digestive Disease Week(i) -- included 1,000 subjects who underwentsedation for colonoscopy and EGD at eight sites and compared the SEDASYS(TM)System to the current standard of care for sedation (midazolam plus fentanylor meperidine). Results were included in Ethicon Endo-Surgery's PreMarketApplication (PMA) for approval of the SEDASYS(TM) System, which is currentlyin review with the U.S. Food and Drug Administration.

"During the trial, the system made it possible for gastroenterologists tomaintain minimal to moderate sedation with propofol, and helped preventpatients from entering deep sedation, which is traditionally associated withpropofol," said Daniel Pambianco, MD, F.A.C.G., medical director ofCharlottesville (Va.) Medical Research and trial investigator.* "The systemoffers a way to personalize the level of sedation appropriate for each patientbecause it combines propofol delivery with sophisticated monitoring to help usbetter control and predict the patient's sedation level."

Patients who received sedation with the SEDASYS(TM) System experiencedfewer and less significant oxygen desaturation events, a clinical sign of oversedation, than patients sedated with current standard of care. The trialdemonstrated this by achieving its primary endpoint of Area Under the Curve(AUC) of oxygen desaturation (SpO2 < 90%). AUC is an objective measure of apatient's respiratory status that incorporates incidence, duration and depthof oxygen desaturation. Patients in the SEDASYS(TM) System group had anaverage AUC value of one-third less than the current standard of carepatients. No device-related adverse events occurred in patients sedated withthe SEDASYS(TM) System.

SEDASYS(TM) System patients were minimally-to-moderately sedated withpropofol during the study. Sedation level was assessed every two minutesusing a Modified Observer's Assessment of Alertness/Sedation (MOAA/S) scale of0-5. Patients who are minimally sedated respond readily when called by name(MOAA/S=5), while moderately sedated patients may require mild tactilestimulus to respond (MOAA/S=2-4). More than 99 percent of SEDASYS(TM) Systempatient responses were a MOAA/S score of 2 -- 5, indicating minimal tomoderate sedation.

Minimal to moderate propofol sedation with the SEDASYS(TM) System providedpatients 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 recoveredwithin 10 minutes. Patient recovery time was measured from scope removal tothe time the patient returned to a MOAA/S=5.

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

"Patients understand that recovery from sedation takes time after acolonoscopy, but with propofol, they recuperate quicker and are functionalsooner," said Dr. Pambianco. "GIs have been performing procedures with currentstandard of care sedatives for years and maintaining a constant sedation levelin patients can be daunting. The novelty of this system is that it has thepotential to accurately tune into my patient's sedation needs by followingtheir vital signs and delivering propofol in a precise manner."


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