News | May 27, 2008

Study Shows SEDASYS System Reduces Risk of Over Sedation of Propofol

May 28, 2008 - Ethicon Endo-Surgery recently released the results of its pivotal trial that 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 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 FDA premarket application for approval of the SEDASYS System, which is currently in review with the FDA. 



“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, M.D., FACG, medical director of Charlottesville 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.”

The trial showed patients who received sedation with the SEDASYS 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

“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.”

For more information: www.ddw.org, www.ethiconendo.com

Related Content

American Cancer Society Updates Colorectal Cancer Screening Guideline
News | Colonoscopy Systems | May 30, 2018
An updated American Cancer Society guideline says colorectal cancer screening should begin at age 45 for people at...
Designed to support a broad range of planning and delivery technologies, SunCheck 2.0 streamlines and standardizes workflows, allowing greater overall focus on patient safety.
Technology | Quality Assurance (QA) | April 27, 2018
Sun Nuclear Corp. released significant new functionality for its SunCheck Platform for patient and machine quality...
Barco Highlights Imaging Workflow Compliance at HIMSS18
News | Flat Panel Displays | February 21, 2018
Barco will showcase its full line of radiology and mammography display systems with online quality assurance (QA)...
FDA Approves Updated Design for Recalled Pentax Duodenoscope
News | Colonoscopy Systems | February 08, 2018
February 8, 2018 – The U.S.
Varian Acquires Mobius Medical Systems
News | Quality Assurance (QA) | February 06, 2018
February 6, 2018 – Varian announced it has acquired privately-held Mobius Medical Systems, a...
Technology | PACS | January 22, 2018
QualiTest Group recently announced its improved Virtual Radiology Environment (VRE) testing solution for picture...
Blue Phantom System Used for Acceptance of First European Varian Halcyon Machine
News | Radiation Therapy | January 02, 2018
IBA (Ion Beam Applications S.A.) announced in November the acceptance and beam model validation of the first Varian...
News | Ultrasound Imaging | November 17, 2017
CIRS Inc. recently announced the acquisition of ATS Laboratories in Bridgeport, Conn. This merger brings together both...
Biodex Unveils Atomlab 500 Dose Calibrator and Wipe Test Counter
Technology | Nuclear Imaging | October 19, 2017
Biodex Medical Systems announced the full release of the Atomlab Dose Calibrator and Wipe Test Counter to the market...
Volpara Solutions to Showcase VolparaEnterprise Live! at RSNA
News | Mammography | October 16, 2017
Volpara Solutions will introduce VolparaEnterprise Live!, a mammography quality control tool, at the 2016 Radiological...
Overlay Init