By Susan Heavey
WASHINGTON, May 27 (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.
A company-funded study of 1,000 patients showed patients sedated with Sedasys recovered in a mean time of 2.7 minutes compared with 6.3 minutes in patients sedated traditionally.
Various experts cite low compliance among Americans who are supposed to undergo a colonoscopy, which is generally recommended for those age 50 or older to detect colon cancer.
But the FDA noted a number of cases where Sedasys patients became unresponsive or lapsed into deep sedation. It said it would ask its outside experts whether the device was safe and effective.
Sedasys monitors patients to help deliver the most accurate drug dose possible, said Ethicon Endo-Surgery's general manager for sedation products, Mike Gustafson. He added it would allow clinicians giving the tests to focus more on patients.
'The device is only going to make conservative drug dosing decisions ... the clinicians are watching the patient using the device as a tool,' he told Reuters.
The American Gastroenterological Association, which represents doctors who give colonoscopies, said it supported computerized sedation and that propofol can be given safely by doctors and nurses who are not trained anesthesiologists.
Requiring anesthesia specialists 'add(s) significant costs to endoscopic procedures, despite no evidence for improved patient outcomes for average risk patients,' it said.
But the American Society of Anesthesiologists (ASA) said it was concerned about patient safety with Sedasys, noting propofol is a potent sedative but inadequate for such tests when used alone.
Anesthesiologists are also trained to anticipate difficult parts of a procedure and adjust medication accordingly, unlike 'a machine reacting to a patient's response,' Donald Martin, an anesthesiology professor at Penn State University, told Reuters on behalf of the ASA.
It is unclear how many doctors' offices, clinics or hospitals would invest in such a device. Gustafson said it was too soon to say how much Sedasys would cost but said that there are 16 million gastroenterological procedures in the United States each year, including 12 million colonoscopies.
Shares of Johnson & Johnson closed down 1.9 percent at $54.22 on the New York Stock Exchange on Wednesday.
(Editing by Brian Moss, Dave Zimmerman and Matthew Lewis) Keywords: JOHNSONANDJOHNSON SEDASYS/ (sheavey@thomsonreuters.com; + 1 202-354-5848) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
WASHINGTON, May 27 (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.
A company-funded study of 1,000 patients showed patients sedated with Sedasys recovered in a mean time of 2.7 minutes compared with 6.3 minutes in patients sedated traditionally.
Various experts cite low compliance among Americans who are supposed to undergo a colonoscopy, which is generally recommended for those age 50 or older to detect colon cancer.
But the FDA noted a number of cases where Sedasys patients became unresponsive or lapsed into deep sedation. It said it would ask its outside experts whether the device was safe and effective.
Sedasys monitors patients to help deliver the most accurate drug dose possible, said Ethicon Endo-Surgery's general manager for sedation products, Mike Gustafson. He added it would allow clinicians giving the tests to focus more on patients.
'The device is only going to make conservative drug dosing decisions ... the clinicians are watching the patient using the device as a tool,' he told Reuters.
The American Gastroenterological Association, which represents doctors who give colonoscopies, said it supported computerized sedation and that propofol can be given safely by doctors and nurses who are not trained anesthesiologists.
Requiring anesthesia specialists 'add(s) significant costs to endoscopic procedures, despite no evidence for improved patient outcomes for average risk patients,' it said.
But the American Society of Anesthesiologists (ASA) said it was concerned about patient safety with Sedasys, noting propofol is a potent sedative but inadequate for such tests when used alone.
Anesthesiologists are also trained to anticipate difficult parts of a procedure and adjust medication accordingly, unlike 'a machine reacting to a patient's response,' Donald Martin, an anesthesiology professor at Penn State University, told Reuters on behalf of the ASA.
It is unclear how many doctors' offices, clinics or hospitals would invest in such a device. Gustafson said it was too soon to say how much Sedasys would cost but said that there are 16 million gastroenterological procedures in the United States each year, including 12 million colonoscopies.
Shares of Johnson & Johnson closed down 1.9 percent at $54.22 on the New York Stock Exchange on Wednesday.
(Editing by Brian Moss, Dave Zimmerman and Matthew Lewis) Keywords: JOHNSONANDJOHNSON SEDASYS/ (sheavey@thomsonreuters.com; + 1 202-354-5848) COPYRIGHT Copyright Thomson Reuters 2009. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.