Ethicon Endo-Surgery SEDASYS(R) System Receives Regulatory Approval in Canada and CE Mark in European Union SEDASYS(R) System Highlighted at DDW 2010
NEW ORLEANS, May 3 /PRNewswire/ -- 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.
About Colorectal Cancer
Colorectal cancer, also known as colon cancer, is one of the deadliest and most expensive diseases to treat. Colon cancer is the second-leading cause of cancer-related deaths in Canada(i) and the third-leading cause of cancer death in the European Union.(ii) It is also the third-leading cause of cancer death in the United States, afflicting nearly 150,000 new patients each year, and claiming the lives of nearly 50,000 more.(iii)
Regular screening tests – such as colonoscopy – are the most effective way to detect abnormal and potentially precancerous growths in the colon or rectum. While there has been an increased demand for colorectal screening, the screening rate remains well below the American Cancer Society's 2015 goal of 75 percent of the eligible population. Contributing factors to patient noncompliance with colonoscopy screening include fear of pain or discomfort and a previous unpleasant experience with an uncomfortable colonoscopy. Propofol (also known as DIPRIVAN®) is considered by physicians to be a preferred sedative for colonoscopies(iv) due to its rapid onset and quick, clear-headed recovery, which enables patients to promptly return to normal activities following a colonoscopy or EGD procedure. New technologies, such as the SEDASYS® System, may help improve patients' experience with colonoscopy and meet the needs of a growing senior population.
About the SEDASYS® System
The SEDASYS® System is the first computer-assisted personalized sedation (CAPS) system designed to provide minimal-to-moderate sedation with propofol. By integrating drug delivery and patient monitoring, the SEDASYS® System enables physician/nurse teams to deliver personalized sedation. 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 System monitors and records patient vital signs and additional parameters, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness. The device is currently an investigational device under review by the U.S. Food and Drug Administration (FDA) and 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.
©2010 Ethicon Endo-Surgery
SEDASYS® is a trademark of Ethicon Endo-Surgery.
DIPRIVAN® is a registered trademark of the AstraZeneca group of companies.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Ethicon Endo-Surgery and/or Johnson & Johnson's expectations and projections. Risks and uncertainties include general industry conditions and competition; economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended January 3, 2010. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ethicon Endo-Surgery nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
(i) Canadian Cancer Society ; http://www.coloncancercanada.ca/fastfacts_coloncancer.php
(ii) P.Boyle, J.Ferlay, "Cancer incidence and mortality in Europe, 2004," Annals of Oncology (2005), 16(5); 481-488
(iii) Colorectal Cancer Facts & Figures, American Cancer Society, 2008
(iv) American Gastroenterological Association press release March 8, 2004. "Gastroenterological Societies Reach Consensus on Recommendations for Sedation During Endoscopic Procedures"
SOURCE Ethicon Endo-Surgery