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FDA Advisory Panel Recommends Approval of the SEDASYS(R) System
Date:5/28/2009

Panel Votes in Favor of Use by Physician/Nurse Teams to Deliver Minimal-to-Moderate Propofol Sedation

CINCINNATI, May 28 /PRNewswire/ -- Ethicon Endo-Surgery today announced that the Anesthesiology and Respiratory Therapy Devices Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of approval of the SEDASYS(R) System for use by physician/nurse teams to administer minimal-to-moderate propofol sedation during screening and diagnostic procedures for colorectal cancer (colonoscopy) and the upper gastrointestinal tract (EGD). The SEDASYS(R) System, the first computer-assisted personalized sedation (CAPS) system, integrates drug delivery and patient monitoring to enable propofol sedation personalized to each patient's needs.

The Anesthesiology and Respiratory Therapy Devices Advisory Committee voted 8 to 2 in favor of approval. Conditions of approval recommended by the Panel included that the SEDASYS(R) System only be used in adult patients age 70 and under, a comprehensive training program, definition of the sedation delivery team and a post-approval study. The final decision regarding approval of the device is made by the FDA.

"There is strong clinical support that the SEDASYS(R) System reduces the risk of over-sedation, which may help make sedation more predictable and reliable for physician/nurse teams," said Kenneth Sumner, Ph.D., Vice President, Clinical and Regulatory Affairs, Ethicon Endo-Surgery, Inc. "We look forward to continuing discussions with the FDA during the regulatory review process."

The Advisory Committee reviewed results from a recent pivotal trial, which were included in the company's Pre-Market Approval (PMA) application for the SEDASYS(R) System. In the study, patients who received sedation with the SEDASYS(R) System experienced fewer and less significant oxygen desaturation events, a clinical sign of over-sedation, than patients sedated
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SOURCE Ethicon Endo-Surgery
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