Ethicon Endo-Surgery Inc. sent a letter to the Food & Drug Administration office of the commissioner in another attempt to advance its appeal of the agency’s denial of approval for its gastroenterology procedure sedation system.
The Cincinnati-based Johnson & Johnson Inc. (NYSE:JNJ) subsidiary expressed its disappointment with the agency over the failure of its device to receive approval, citing the 8-2 vote in favor of approval by an FDA-appointed advisory panel.
“We remain fully committed to working with the FDA to secure approval of the Sedasys System because of the potential benefits it can bring to gastroenterology patients and providers. [We] believe appealing to the commissioner’s office is our best path forward to ensure a thorough reconsideration of the Sedasys System clinical trial data and application," company group chairwoman Karen Licitra said in prepared remarks.
The company first filed a petition for reconsideration in March, after receiving its first non-approval notification from the Center for Devices and Radiological Health, the FDA’s medical device wing. The CDRH, however, responded with another denial letter in October.
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, according to the company. Ethicon said if the office of the commissioner grants the appeal, the FDA would appoint a new advisory committee and hold a public hearing on the device. The final decision would then be in the hands of FDA commissioner Dr. Margaret Hamburg.
EES describes the Sedasys System as the "first-of-its-kind computer-assisted personalized [propofol] sedation system for colonoscopy and upper gastrointestinal procedures." The company designed the device to provide integrated patient monitoring with personalized drug delivery. The 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.