Ethicon Endo-Surgery (EES), a Johnson & Johnson company, has received the Commissioner’s Office of the US Food and Drug Administration (FDA) grant for the appeal of the Center for Devices and Radiological Health’s (CDRH) denial for the Sedasys System pre-market approval application (PMA).
The Sedasys System is a 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 and 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 Company Group chair and Worldwide Franchise chair Karen Licitra said that they look forward to the new Independent Advisory Panel review to reconsider their clinical trial data, which demonstrated the System is safe and effective.