CINCINNATI—Ethicon Endo-Surgery Inc. recently won an appeal to the Food & Drug Administration in an effort to get the FDA to consider reversing its denial of Ethicon’s Sedasys System pre-market approval application.
The FDA's Center for Devices and Radiological Health initially denied the company's pre-market approval application for the gastroenterology procedure sedation system. The appeal means the FDA will appoint a new advisory committee and hold a public hearing on the device, with a final decision falling to FDA commissioner Dr. Margaret Hamburg.
"We look forward to the new Independent Advisory Panel review to reconsider our clinical trial data, which demonstrated the system is safe and effective," company group chairwoman Karen Licitra said in prepared remarks. The Johnson & Johnson subsidiary sent a letter to the FDA commissioner for the appeal last week.
Cincinnati-based Ethicon Endo-Surgery first filed a petition for reconsideration in March, after receiving its first non-approval notification from the CDRH, but the FDA's medical device wing responded with another denial letter in October, according to the company. Appeal is a rarely used part of the pre-market approval application process that device and drug companies can pursue when one of the centers within FDA denies their product's application.
Ethicon describes the Sedasys System as the "first-of-its-kind computer-assisted personalized [propofol] sedation system for colonoscopy and upper gastrointestinal procedures." The device is designed to provide integrated patient monitoring with personalized drug delivery. The company said the device "would help reduce sedation-related risks associated with colonoscopies, improve the overall patient experience, and encourage more individuals to be screened for colon cancer, which kills more than 50,000 Americans each year." The system has already received European CE Mark approval and Australian approval.
Source: MassDevice staff