FDA grants SEDASYS System appeal

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 look forward to the new Independent Advisory Panel review to reconsider our clinical trial data, which demonstrated the System is safe and effective.”

"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.