Ethicon Endo-Surgery's Sedasys System limits oxygen deficiency during routine colonoscopy and upper GI procedures and leads to shorter patient recovery times, according to a study scheduled to appear in the journal Gastrointestinal Endoscopy.
The manufacturer-funded research backs the company's claims that GI physicians and nurses can use the computer-assisted personalized sedation system to safely deliver propofol without involving an anesthesiologist.
Researchers compared the incidence, depth and duration of oxygen desaturation events as well as sedation levels, patient and surgeon satisfaction, and recovery times of 1,000 patients sedated with the Sedasys System or a benzodiazepine and opioid cocktail. Most patients in both groups were minimally-to-moderately sedated, note the researchers.
They report that oxygen desaturation was "significantly" lower in patients sedated by the Sedasys System. In addition, physician and patient satisfaction were greater and post-procedure recovery times shorter in the Sedasys System group, according to the study. The incidences of adverse events were 5.8% and 8.7% in the Sedasys System and benzodiazepine/opioid cohorts, respectively.
The FDA rejected the Sedasys System last April, despite a recommendation for approval from an advisory panel of outside experts. Then in November, the FDA granted Ethicon Endo-Surgery's appeal of the pre-market denial, meaning a new independent advisory panel will reconsider approving Sedasys for use within the United States.
Ethicon Endo-Surgery continues to stand by its assertions that the device is a safe and effective alternative to benzodiazepine-based sedation. "We believe the Sedasys System has the potential to help reduce sedation-related risks associated with endoscopic procedures, improve the patient experience and encourage more individuals to get screened for colon cancer," says Michael Gustafson, general manager of Ethicon Endo-Surgery's Sedation Systems. "We remain committed to bringing (it) to (market)."
Daniel Cook
