FDA Review of Propofol Administration Device in Limbo

The Food and Drug Administration’s decision not to approve a computer-assisted personalized sedation system known as the SEDASYS System has been appealed by the manufacturer, Ethicon Endo-Surgery Inc. The device is designed to administer propofol during colonoscopy and esophagogastroduodenoscopy procedures.

Because the manufacturer has appealed the decision, an independent advisory panel will review the decision, but at press time, the date of the review and other details were not available.

In October, the FDA sent a letter to the company denying the approval of the SEDASYS System, which the company had proposed be approved for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion "for the initiation and maintenance of minimal-to-moderate sedation" in adults undergoing these procedures.

The approval of the device would enable gastroenterologists and nurses to administer propofol to patients during such procedures without an anesthesiologist present; however, the system is not designed for the induction or maintenance of general anesthesia.

According to the FDA, the information submitted by the company "does not provide a reasonable assurance that the device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling," and this is why in February 2010, the agency notified the company that the device was not approvable.

But Ethicon Endo-Surgery chose not to address the issues raised by the FDA and chose instead to consider the nonapprovable decision as denial of approval, which, under federal regulations, allows the company to appeal and request an administrative review of the decision by an independent advisory panel.

In November, Ethicon announced that the FDA had granted the company an appeal of the decision and would appoint an independent advisory panel to "reconsider" the clinical trial data and application.

Among the problems with the company’s application cited in the FDA’s October letter were insufficient evidence of the device’s safety in the pivotal study, when used by clinicians who are not trained in the administration of general anesthesia. The study did not compare propofol sedation administered with the SEDASYS system by gastroenterologists and nurses to propofol sedation administered by clinicians trained in general anesthesia, the FDA-approved labeling for the sedative. As a result, the letter says," "we cannot evaluate the distinct risks in administering propofol utilizing the SEDASYS system in comparison with propofol delivery in accordance with FDA-approved drug labeling without the device."

In May 2009, an FDA advisory panel voted 8 to 2 to recommend approval of the device for the indication proposed by the manufacturer, under several conditions, including requiring that clinicians using the device be trained in advanced airway management and that they not be involved in other aspects of the procedure.

Find more information about the FDA’s decision.