Ethicon Endo-Surgery, the makers of the Sedasys computer-assisted sedation system, will appeal the denial of its pre-market approval application before an FDA dispute resolution panel next month.
Sedasys lets gastroenterologists and their nurses administer propofol during colonoscopy and endoscopy without an anesthesia provider present. In 2009, the FDA's Anesthesiology and Respiratory Therapy Devices Advisory Committee voted 8-2 in favor of the FDA approving the device, but the agency rejected that recommendation in 2010. Now that the FDA has granted Ethicon Endo-Surgery a hearing to appeal its decision, the company will plead for approval one more time.
In its "not approvable" letter from 2009, the FDA told the company it had not proven that there was a reasonable assurance Sedasys was safe, writing that "the Sedasys System is associated with an increased incidence of deeper-than-intended sedation." The company countered that the device has a built-in safety feature to avoid apnea and loss of oxygen.
Outside the United States, Sedasys has been granted a CE Mark for the European Union and is approved in Australia for colonoscopy and EGD procedures. Health Canada also granted regulatory approval for Sedasys during routine colonoscopies.
Dan O'Connor
