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After initially rejecting Ethicon's computer-assisted sedation system, FDA finally grants a PMA
FDA approved the first computer-assisted sedation system in the world made by Johnson & Johnson's Ethicon Endo -Surgery after rejecting it previously.
May 6, 2013
2 Min Read
The first computer-assisted sedation system in the world made by Johnson & Johnson's Ethicon Endo-Surgery division has had a bumpy road to regulatory approval.
An FDA panel recommended approval for the Sedasys System back in 2009, according to the American Society of Gastrointenstinal Endoscopy but FDA rejected it in 2010. After an appeals process, Ethicon has announced that the FDA has finally approved its PMA device that allows a physician-led team to use the device to provide sedation to healthy patients undergoing routine colonoscopy and esophagogastroduodenoscopy (EGP) procedures who are at least 18 years old.
The American Society of Gastrointenstinal Endoscopy believes that the Sedasys System can reshape the world of endoscopic procedures because it can administer propofol without a trained anesthesiologist on hand. Having a trained anesthesiologist for certain routines endoscopic procedures is expensive and this has limited the use of propofol, which is regarded as a better sedative because it gets to work quickly and has a "short half life" that leads to faster recovery, according to a report that ASGE prepared about computer-assisted sedation systems in 2011.
"Computer-assisted personalized sedation (CAPS) devices seek to make the delivery of propofol sedation predictable, precise, and safe by using computer algorithms to calculate and deliver appropriate amounts of propofol, based on quantiï¬able physiological parameters," the report said.
In its news release, Ethicon Endo Surgery said that it estimates 15 million U.S. patients are candidates for the Sedasys System, and it plans a limited commercial launch of the product in 2014. The news release appears to imply that the company is taking a cautious approach to bring the product to market.
In introducing this first-of-its-kind technology, the company will offer the SEDASYS System to facilities where an anesthesia professional is immediately available for assistance or consultation. In addition to receiving device-specific training, the member of the physician-led team who is administering sedation must have training in the management of cardiorespiratory effects of propofol.
"The SEDASYS System will address the growing preference for propofol sedation in gastroenterology by more closely matching the skill level of the sedation delivery team with the actual requirements of less complex cases," said Dr. Daniel Pambianco, Medical Director, Charlottesville Medical Research, Charlottesville, Va and Principal Investigator. [He is also a paid consultant] "The technology will empower health care facilities to more effectively use their limited resources to deliver greater value in the increasingly resource-constrained U.S. health care environment."
-- By Arundhati Parmar, Senior Editor, MD+DI
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