Ethicon Endo-Surgery (EES) has urged the Office of the Commissioner of the Food and Drug Administration (FDA) to grant the company’s appeal of the Center for Devices and Radiological Health’s (CDRH) denial of the Sedasys System premarket approval application (PMA).
The Sedasys System is a computer-assisted personalised sedation system for colonoscopy and upper gastrointestinal (EGD) procedures.
As part of the appeals process, CDRH has issued a denial letter, which EES has received on October 26, 2010.
The Sedasys system was designed in collaboration with anesthesiologists, clinical pharmacologists and anesthesia device experts for physician/nurse teams to provide minimal-to-moderate sedation with propofol during colonoscopy and esophagogastroduodenoscopy (EGD) procedures.
The system integrates physiological patient monitoring with personalised drug delivery and is designed to maximise patient safety.
EES company group chair and worldwide franchise chair Karen Licitra said that they 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 have been in conversations with the FDA for several months and 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,” Licitra said.