The FDA has rejected Ethicon Endo-Surgery's application for approval of its computer-assisted personalized sedation system, Sedasys, the company revealed in a conference call with analysts this week.
Although an advisory panel of outside experts recommended last May that the FDA approve the Sedasys machine, which is designed to administer propofol to colonoscopy patients without the need for a clinician trained in general anesthesia, Ethicon's parent company Johnson & Johnson says it recently received a "not approvable letter" for the device from the FDA. Louise Mehrotra, head of J&J's investor relations, says the company has appealed to the FDA commissioner's office, requesting administrative review by an independent advisory committee.
"We are disappointed by the FDA's decisions, especially following a successful clinical program and FDA advisory panel recommendation for approval," said Ms. Mehrotra during the April 20 call announcing the company's first-quarter results. "We remain committed to and excited about the future of the Sedasys system in the U.S. and the clinical benefits it can bring to patients, physicians and nurses."
J&J spokeswoman Kelly Leadem says the not approvable letter "does not mean the FDA found the system to be unsafe or ineffective." Instead, the letter "provided options that can be taken toward approval," such as doing additional clinical studies on the Sedasys. She declined to elaborate on other options mentioned in the letter and said the FDA has not yet responded to J&J's appeal.
Sedasys is currently approved for use during colonoscopies in both the European Union and Canada.
Irene Tsikitas
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