Public HealthFDA Advisory Panel Recommends Approval Of The SEDASYS(R) System
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 with the current standard of care drugs -- benzodiazepines and opioids.
The SEDASYS(R) System automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea), guided by continual monitoring and recording of critical patient vital signs, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness.
Propofol (also known as DIPRIVAN(R)) is considered by physicians to be a preferred sedative due to its rapid onset and quick, clear-headed recovery, which enables patients to promptly return to normal activities following a colonoscopy or EGD procedure. Current propofol labeling states only persons trained in the administration of general anesthesia should administer the drug. In the majority of practice settings, gastroenterologists do not have broad access to anesthesiologists.
About the SEDASYS(R) System
The SEDASYS(R) System is the first computer-assisted personalized sedation (CAPS) system designed for physician/nurse teams to provide minimal-to-moderate sedation levels with propofol. By integrating drug delivery and patient monitoring, the SEDASYS(R) System enables physician/nurse teams to deliver personalized sedation. It automatically detects and responds to signs of over-sedation (oxygen desaturation and low respiratory rate/apnea) by stopping or reducing delivery of propofol, increasing oxygen delivery and automatically instructing patients to take a deep breath. The device is currently an investigational device limited by U.S. law to investigational use only.
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.
(C)2009 Ethicon Endo-Surgery
SEDASYS(R) is a trademark of Ethicon Endo-Surgery.
DIPRIVAN(R) is a registered trademark of the AstraZeneca group of companies.
Ethicon Endo-Surgery