* FDA advisory panel votes 8-2 in favor of Sedasys
* Panelists call for age limitations, extra studies
* Ethicon: will spend months discussing device with FDA (Adds panel and company comments, background, byline)
WASHINGTON, May 28 (Reuters) - A U.S. advisory panel recommended on Thursday approval of Johnson & Johnson's JNJ.N computerized sedation machine, Sedasys, for use with colonoscopy and upper gastrointestinal tract exams.
The Food and Drug Administration panel of outside experts voted 8 to 2 in favor of the device, as long as its use was limited to adults 70 and younger and additional studies were conducted, among other conditions.
“I believe that this device does have the potential to improve patient safety,” said panel member Dr. Jeffrey Kirsch, an anesthesiologist at Oregon Health and Science University in Portland.
Sedasys aims to monitor patients' vital signs while intravenously delivering propofol, a sedative available as a generic drug, or as AstraZeneca Plc's AZN.L Diprivan. The company's Ethicon Endo-Surgery unit is seeking to sell it for use during colonoscopy or upper gastrointestinal exams by clinicians who are not anesthesiologists.
The agency will weigh the panel’s recommendation before later making its final approval decision.
Ethicon officials declined to say when the company expected an FDA decision but said they would be in discussions with the agency for the next few months. The company submitted its application to the agency March 27, 2008.
Despite their support, the panel expressed concern about having a machine deliver a powerful sedative rather than having a doctor or nurse directly administer it as is current practice.
They said the FDA should require the device to be used in teams of at least three clinicians with one doctor or nurse devoted to handling the machine. Special doctor training should also be mandated, they added.
Overall, most panel members agreed with Ethicon officials that Sedasys could provide automated sedation with fewer side effects to ease patients’ worries, especially when it comes to colonoscopy exams to detect colon cancer.
Ethicon officials told the panel its device offered more controlled dosing and allowed patients to recover faster. A company study of 1,000 patients showed those sedated with Sedasys recovered in a mean time of 2.7 minutes compared with 6.3 minutes in patients sedated by normal means.
“It will definitely improve the compliance with colorectal cancer screening,” said panel member Dr. Timothy Nostrant, a gastroenterologist at the University of Michigan in Ann Arbor.
Colonoscopy exams are generally recommended for people age 50 or older to detect colon cancer but various experts say compliance is low.
About 16 million gastroenterological procedures, including 12 million colonoscopies, are done in the United States each year, according to the company.
Not all the panelists agreed that the company’s data showed Sedasys was safe and effective enough for approval.
“This thing needs more evidence,” said panel member Karen Domino, an anesthesiologist at the University of Washington School of Medicine in Seattle. (Editing by Andre Grenon; Editing by Steve Orlofsky)
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