ETHICON ENDO-SURGERY SUBMITS APPLICATION TO FDA FOR APPROVAL OF THE
SEDASYS™ SYSTEM – THE FIRST COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM
CINCINNATI, OH - March 27, 2008 – 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™ System, the first
computer-assisted personalized sedation (CAPS) system.
The SEDASYS™ 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 EGD
procedures, physicians prefer the sedative propofol (also known as DIPRIVAN®),
which produces rapid onset and quick recovery for patients .
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™ 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.
DSL#08-0281 ©Ethicon Endo-Surgery, Inc. 2008
SEDASYS is a trademark of Ethicon Endo-Surgery
DIPRIVAN® is a registered trademark of the AstraZeneca group of companies.
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(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.)
