Ethicon Endo-Surgery appeals FDA denial of sedation system

Surgical device company Ethicon Endo-Surgery Inc. has appealed the federal government's denial of its application to begin selling a sedation system for colonoscopy and upper gastrointestinal procedures.

Surgical device company Ethicon Endo-Surgery Inc. has appealed the federal government’s denial of its application to begin selling a sedation system for colonoscopy and upper gastrointestinal procedures.

Without approval from the Food and Drug Administration, the Cincinnati-based company can’t legally sell its computer-assisted Sedasys system in the United States. Ethicon Endo-Surgery is a division of Johnson & Johnson.

In a statement announcing its appeal, Ethicon didn’t directly say why the FDA denied its Premarket Approval Application to begin selling the system, and a spokeswoman didn’t immediately return a call.

However, from the statement’s tone, it appears the FDA objected to the company’s proposed labeling for the device. The labeling would allow gastroenterologist and nurse teams to administer the sedative drug propofol without an anesthesia professional present. An independent FDA advisory panel earlier voted 9-1 that doctors and nurses using the system don’t have to be trained in administering general anesthetic.

The FDA division that denied Ethicon’s application — the Center for Devices and Radiological Health — apparently didn’t agree with the panel’s assessment, or Ethicon, for that matter.

The Sedasys has received regulatory approval for sale in the European Union, Australia and Canada. The system integrates physiological patient monitoring with personalized drug delivery and could help reduce risks associated with sedation, according to Ethicon.

The sedative drug used by Ethicon’s system, propofol, received its moment in the sun last year when a Los Angeles coroner found that an overdose of the drug killed pop star Michael Jackson.

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