Ethicon Endo-Surgery SEDASYS CAPS system receives European Union CE Mark, Health Canada approval

Ethicon Endo-SurgeryMay 3 2010

Ethicon Endo-Surgery today announced that the SEDASYS® System, the first computer-assisted personalized sedation (CAPS) system, was granted a CE Mark for the European Union for routine colonoscopy and screening of the upper gastrointestinal tract (EGD procedures), and Health Canada granted regulatory approval for the SEDASYS® System for use by healthcare professional teams during routine colonoscopy. The SEDASYS® System, which is featured in poster presentations at Digestive Disease Week (DDW) 2010, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient's needs.

"We are excited by these regulatory approvals and the opportunities they provide to bring the SEDASYS® System to the Canadian and European markets," said Karen Licitra, Company Group Chair and Worldwide Franchise Chair, Ethicon Endo-Surgery. "We believe the SEDASYS® System has the potential to improve the sedation experience for patients and clinicians during routine colonoscopy procedures, and we look forward to the launch of the System in these markets, as early as the end of this year."

DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. The SEDASYS® System is featured in two poster presentations at DDW. These posters describe post-hoc analyses of data from a multi-center, prospective, randomized, controlled pivotal trial of 1,000 patients that compared the safety and effectiveness of the SEDASYS® System to current standard of care drugs – benzodiazepines and opioids – for sedation during endoscopic procedures (colonoscopy and EGD). The two posters are:

• "Level of Sedation and Patient/Clinician Satisfaction" (Date of Presentation: May 3) – the study demonstrated patients who underwent routine colonoscopy and EGD procedures were satisfied with minimal-to-moderate sedation and their satisfaction did not increase as the level of sedation deepened. Consistent with the pivotal study, the clinicians were more satisfied with the procedures that involved propofol sedation delivered with the SEDASYS® System compared to the procedures in which patients were sedated with the current standard of care drugs.
• "A Novel Patient Responsiveness Monitor for Minimal/Moderate Sedation" (Date of Presentation: May 5) – the study showed that the SEDASYS® System's automated responsiveness monitor (ARM) is able to reliably assess a patient's level of sedation and notify a clinician when a transition from moderate to deep sedation may occur. The SEDASYS® System, with the ARM, enabled the clinician to maintain patients at minimal-to-moderate sedation, reducing episodes of deep sedation and general anesthesia.