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Ethicon Endo-Surgery Submits Application to FDA for Approval of the SEDASYS(TM) System - the First Computer-Assisted Personalized Sedation System
CINCINNATI
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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
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
(i) American Gastroenterological Association press release
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