Ethicon Endo-Surgery, Inc. Submits Application to FDA for Approval of the SEDASYS(TM) System
Published: Mar 27, 2008
CINCINNATI, March 27 /PRNewswire/ -- Ethicon Endo-Surgery announced today that the company has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the SEDASYS(TM) System, the first computer-assisted personalized sedation (CAPS) system.
The SEDASYS(TM) System is intended for use by physician/nurse teams to administer minimal to moderate propofol sedation to patients undergoing screening and diagnostic procedures for colorectal cancer (colonoscopy), and disorders of the upper gastrointestinal tract (EGD). For routine colonoscopy or EDG procedures, physicians prefer the sedative propofol (also known as DIPRIVAN(R)), which produces rapid onset and quick recovery for patients(i).
The PMA submission includes results from a multi-center prospective, randomized, controlled trial of 1,000 patients that compared the safety and effectiveness of the SEDASYS(TM) System to the current standard of care for sedation in routine endoscopic procedures - physician-administered benzodiazepine and opioids. The pivotal clinical trial was conducted from March 2007 to October 2007 at eight locations in the U.S.
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.
SEDASYS is a trademark of Ethicon Endo-Surgery
DIPRIVAN(R) 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 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 the Company's Annual Report on Form 10-K for the fiscal year ended December 30, 2007. 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. Johnson & Johnson does not undertake to update any forward- looking statements as a result of new information or future events or developments.)
(i) American Gastroenterological Association press release March 8, 2004. "Gastroenterological Societies Reach Consensus on Recommendations for Sedation During Endoscopic Procedures"
CONTACT: Media: Kelly Leadem, +1-513-337-1006, Wendy Dougherty,
+1-513-337-8281, both of Ethicon Endo-Surgery, or Investor Relations: Stan
Panasewicz, +1-732-524-2524, Louise Mehrotra, +1-732-524-6491, both of
Johnson & Johnson
Web site: http://www.ethiconendo.com/