Ethicon Endo-Surgery appeals FDA for Sedasys system
Ethicon Endo-Surgery appeals FDA for Sedasys system
Ethicon Endo-Surgery (EES) is urging 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. But CDRH has issued a denial letter. The Sedasys system was designed together with anesthesiologists, clinical pharmacologists and anesthesia device experts for physician/nurse teams to provide minimal-to-moderate sedation during colonoscopy and esophagogastroduodenoscopy (EGD) processes.
It has been formulated to maximize patient safety and also to integrate physiological patient monitoring with personalized drug delivery.
EES company group chair and worldwide franchise chair Karen Licitra is confident of the potential benefits it can offer to gastroenterology patients and providers. The company plans to closely work with the FDA to secure approval of the Sedasys System.
Licitra said: "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"
The SEDASYS System has been granted a CE Mark for the European Union for routine colonoscopy and screening of the upper gastrointestinal tract (EGD procedures). Health Canada too granted regulatory approval for the SEDASYS System to be used by healthcare professionals during routine colonoscopy.
The computer-assisted System is featured in poster presentations at Digestive Disease Week (DDW) 2010. It showcases how drug delivery and patient monitoring can allow propofol sedation which can be customized to each patient's requirements.