Ethicon Endo-Surgery, Inc.'s SEDASYS(R) System Appeal Has Been Granted by the FDA
CINCINNATI--(BUSINESS WIRE)--Ethicon Endo-Surgery, Inc. (EES) today announced that the Commissioner’s Office of the U.S. Food and Drug Administration (FDA) has granted the appeal of the Center for Devices and Radiological Health’s (CDRH) denial of the SEDASYS® System Premarket Approval Application (PMA). As a result, a new Independent Advisory Panel will be appointed to reconsider the SEDASYS® System clinical trial data and application.
“We appreciate that the Commissioner’s Office has granted our appeal of the SEDASYS® System PMA application,” said Karen Licitra, Company Group Chair and Worldwide Franchise Chair, EES. “We look forward to the new Independent Advisory Panel review to reconsider our clinical trial data, which demonstrated the System is safe and effective.”
The SEDASYS® System is the first computer-assisted personalized sedation (CAPS) system designed to allow physician/nurse teams to provide minimal-to-moderate sedation with propofol during routine upper and lower gastrointestinal procedures in healthy adults. The SEDASYS® System has the potential to benefit patients, physicians and nurses. If approved, it may help reduce sedation-related risks associated with endoscopic procedures, may improve the overall patient experience, and may encourage more individuals to be screened for colon cancer.
EES filed its appeal on March 26, 2010, after receiving a Not-Approvable Letter from CDRH despite an 8-2 vote by CDRH’s Anesthesiology and Respiratory Therapy Devices Advisory Committee, which reviewed the clinical data last year.
Outside the U.S., the SEDASYS® System has been granted a CE Mark for the European Union and is approved in Australia for colonoscopy and EGD procedures. Health Canada also granted regulatory approval for the SEDASYS® System for use by healthcare professional teams during routine colonoscopies.
About the SEDASYS® System
The SEDASYS® System is the first computer-assisted personalized sedation (CAPS) system designed to allow physician/nurse teams to provide minimal-to-moderate sedation with propofol during routine endoscopy procedures in healthy adults. By integrating state-of-the-art drug delivery and patient monitoring, the SEDASYS® 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 SEDASYS® System monitors and records patient vital signs and additional parameters, including oxygen saturation, respiratory rate, heart rate, blood pressure, end-tidal carbon dioxide and patient responsiveness. 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. More information can be found at www.ethiconendo.com.
©2010 Ethicon Endo-Surgery
SEDASYS® is a trademark of Ethicon Endo-Surgery.
(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 Ethicon Endo-Surgery and/or 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 Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 3, 2010. 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. Neither Ethicon Endo-Surgery nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)