FDA staff questions J&J sedation device data

By Susan Heavey

WASHINGTON (Reuters) - A study of Ethicon Endo-Surgery Inc's computerized system to help sedate patients undergoing a colonoscopy showed it was effective but other factors may have played a role, the U.S. Food and Drug Administration said in a memo released on Wednesday.

The unit, called Sedasys, monitors patients' vital signs while intravenously delivering the sedative drug propofol -- made by a variety of manufacturers as a generic and also by AstraZeneca under the brand name Diprivan.

Ethicon Endo-Surgery, part of Johnson & Johnson, is seeking approval to market the device for use for patients undergoing a colonoscopy by healthcare providers with no special training in general anesthesia.

The FDA document was released ahead of a public meeting on Thursday when the agency will seek recommendations from outside advisers on whether to approve the product.

While a company study showed Sedasys was superior to current sedation methods, FDA staff noted "a marked study site effect" that showed "investigator behavior rather than product performance may have favored the Sedasys System."

Ethicon Endo-Surgery is also seeking approval for tests to diagnose upper gastrointestinal tract disorders but data for that indication did not meet its goals, the FDA said.

Company officials, in a separate document, said Sedasys provides automated sedation with fewer side effects which could help ease patients' concerns about colonoscopies and encourage more people to get the procedure.

Sedasys does not change the actual colonoscopy procedure itself, but company officials said it helped control dosing and allowed patients to recover faster.