May 28, 2009
FDA Panel Deems SEDASYS Approvable With Conditions
On May 28, 2009, the FDA's Anesthesia and Respiratory Therapy Devices Advisory Committee voted 8-2 that Ethicon Endo-Surgery’s application for premarket approval of it SEDASYSTM Computer-Assisted Personalized Sedation System be approvable for its proposed indication with 4 conditions. SEDASYSTM is indicated for the intravenous administration of 1% (10 milligrams/milliliters) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation as identified by the ASA Continuum of Depth of Sedation, in adult patients (ASA physical status I or II) undergoing colonoscopy and EGD procedures. ASA oral testimony was provided by Dr. Donald Martin of Pennsylvania at the meeting.
The “approvable” vote is different than “approve” and means that the panel believes the device could be approved if the company meets the conditions it recommended. The 4 conditions approved include:
- The device may only be used in adult patients 70 years old or younger;
- The device may only be used in the presence of a 3 person clinical team where one person (with at least RN training) shall have the sole responsibility of monitoring the patient, the device and managing the patient's airway;
- GI physicians utilizing the device must complete training given by a clinician with the clinical experience and credentials to provide and rescue patients from deep sedation and general anesthesia. The training shall included advanced airway management, pharmacology of propofol and opiods, patient selection, monitor training (such as SpO2 monitoring), device set-up and maintenance and a program shall be established for continuing education in these areas; and finally
- Completion of all post-marketing studies proposed by the manufacturer as well as a controlled launch of the product.
Those members of the panel voting against approval included: Dr. Karen Domino, an anesthesiologist from Washington and Dr. Donald Prough, an anesthesiologist from Texas.
It is important to note that the panel vote is only one step in the approval process. The FDA will now take the advice of the panel into consideration as it makes it own determination on the final approval of the device, a process that will likely take several months. During that time the FDA and Ethicon work out the details of the final labeling as well as the conditions. ASA will continue to monitor the progress and work with the FDA to ensure the safe use of the device.