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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
Date:3/27/2008

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 http://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 expecta
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SOURCE Ethicon Endo-Surgery
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