May 07, 2013
FDA Grants Premarket Approval for SEDASYS (R)
On May 3, 2013, Ethicon Endo-Surgery, Inc. announced that the Food and Drug Administration (FDA) granted Premarket Approval for the SEDASYS® system, a computer-assisted personalized sedation system. SEDASYS® is indicated "for the intravenous administration of 1 percent (10 milligrams/milliliters) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as identified by the American Society of Anesthesiologists Continuum of Depth of Sedation, in adult patients (American Society of Anesthesiologists physical status I or II) undergoing colonoscopy and esophagoduodenoscopy procedures." News reports indicate that SEDASYS® is expected to be introduced on a limited basis beginning in 2014.
ASA provided formal written and oral comments in 2009 to the FDA Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee regarding the SEDASYS® system in which concerns were expressed regarding the patient safety implications of the device. Public information related to the Premarket Approval is currently under review by ASA and will be made available as soon as the review is completed.
Learn more about the FDA’s premarket approval process.