SAN DIEGO, May 19 CA-Over-Sedation-Risk
SAN DIEGO, May 19 /PRNewswire/ -- DDW 2008 Annual Meeting -- Ethicon
Endo-Surgery announced today that the results from its pivotal trial
demonstrated physician/nurse teams using the SEDASYS(TM) 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(TM)
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(TM) System, which is currently
in review with the U.S. Food and Drug Administration.
"During the trial, the system made it possible for gastroenterologists to
maintain minimal to moderate sedation with propofol, and helped prevent
patients from entering deep sedation, which is traditionally associated with
propofol," said Daniel Pambianco, MD, F.A.C.G., medical director of
Charlottesville (Va.) Medical Research and trial investigator.* "The system
offers a way to personalize the level of sedation appropriate for each patient
because it combines propofol delivery with sophisticated monitoring to help us
better control and predict the patient's sedation level."
Patients who received sedation with the SEDASYS(TM) System experienced
fewer and less significant oxygen desaturation events, a clinical sign of over
sedation, than patients sedated with current standard of care. The trial
demonstrated this by achieving its primary endpoint of Area Under the Curve
(AUC) of oxygen desaturation (SpO2 < 90%). AUC is an objective measure of a
patient's respiratory status that incorporates incidence, duration and depth
of oxygen desaturation. Patients in the SEDASYS(TM) System group had 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."
The study determined that clinicians were significantly more satisfied
with the level of sedation achieved with the SEDASYS(TM) System than with
current standard of care. Clinicians evaluated sedation administration using
the Clinician Satisfaction with Sedation Instrument (CSSI). Additionally,
patients sedated with the SEDASYS(TM) System were more satisfied with the
sedation they received. Patients evaluated sedation using the Patient
Satisfaction with Sedation Instrument (PSSI).
About the SEDASYS(TM) System
The SEDASYS(TM) System is the first computer-assisted personalized
sedation (CAPS) system designed for physician/nurse teams to provide minimal
to moderate sedation levels with propofol. By integrating drug delivery and
patient monitoring, the SEDASYS(TM) System enables physician/nurse teams to
deliver personalized sedation. The device continuously monitors and records
six patient parameters including oxygen saturation, respiratory rate, heart
rate, blood pressure, end-tidal carbon dioxide and patient responsiveness. It
automatically detects and responds to signs of over sedation (oxygen
desaturation and low respiratory rate/apnea) by stopping or reducing delivery
of propofol, increasing oxygen delivery and automatically instructing patients
to take a deep breath. The device is currently an investigational device
limited by U.S. law to investigational use only.
About Ethicon Endo-Surgery
Ethicon Endo-Surgery, a Johnson & Johnson company, develops and markets
advanced medical devices for minimally invasive and open surgical procedures,
focusing on procedure-enabling devices for the interventional diagnosis and
treatment of conditions in general and bariatric surgery, as well as
gastrointestinal health, gynecology and surgical oncology. More information
can be found at www.ethiconendo.com .
About DDW
DDW is the largest international gathering of physicians, researchers and
academics in the fields of gastroenterology, hepatology, endoscopy and
gastrointestinal surgery. Jointly sponsored by the American Association for
the Study of Liver Diseases, the American Gastroenterological Association
(AGA) Institute, the American Society for Gastrointestinal Endoscopy and the
Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008,
at the San Diego Convention Center, San Diego, CA. The meeting showcases
approximately 5,000 abstracts and hundreds of lectures on the latest advances
in GI research, medicine and technology. For more information, visit
www.ddw.org .
(C)2008 Ethicon Endo-Surgery
SEDASYS is a trademark of Ethicon Endo-Surgery
DIPRIVAN(R) is a registered trademark of the AstraZeneca group of
companies.
*Consultant to Ethicon Endo-Surgery following completion of pivotal trial.
(i) DDW Abstract # 682d
(ii) American Cancer Society Guidelines for the Early Detection of Cancer,
http://www.cancer.org/docroot/ped/content/ped_2_3x_acs_cancer_detection_guidel
ines_36.asp
SOURCE Ethicon Endo-Surgery
