|J&J's automated anesthesiology system--Courtesy of Sedasys|
Sedasys, a division of J&J's ($JNJ) Ethicon arm, won the FDA's approval of what is being billed as the first computer-assisted sedation system. An initial rollout is expected starting in 2014. The medical device is designed to administer minimal-to-moderate propofol sedation, initially for endoscopy procedures, and the company will focus on educating gastroenterologists, anesthesiologists and nursing experts on the new system.
J&J/Ethicon/Sedasys doesn't have a clean shot to market, however. It must also pursue two postapproval clinical studies to gauge how the system works during actual clinical use, among other requirements.
Initial clinical trials found that patients using the Sedasys automated anesthesiology system recovered faster than those in the control group and also had fewer issues with oxygen desaturation than those sedated with benzodiazepines or opioid drugs.
The idea is that computer-controlled sedation could be safer for patients and help reduce errors or oversedation that can happen manually. And J&J isn't alone in pursuing this goal. MIT Technology Review reported in October, for example, that an MIT scientist has advanced a related EEG system to help monitor a patient's sedation through sensors on the scalp, with the idea of better maintaining a patient in a medically induced coma.
J&J/Ethicon/Sedasys sees a potential market for its computer-aided surgical sedation system that could hit as many as 15 million patients in the U.S. alone. That estimate reflects Sedasys' potential draw for hospitals seeking to cut costs. As The Wall Street Journal noted last fall, Sedasys would cost about $150 per procedure, versus the $600 to $2,000 anesthesiologists commonly charge.
J&J gains a pivotal PMA for its computer-aided surgical sedation device