Johnson & Johnson (JNJ) achieved a pivotal FDA PMA approval for what is being billed as the first computer-assisted sedation system, now available for endoscopy procedures.
Sedasys, a division of the company’s Ethicon arm, obtained the new regulatory nod.
Plans are for a gradual rollout beginning in 2014. In the interim, J&J/Ethicon/Sedasys plans to work with gastroenterology, anesthesiology and nursing professionals to educate them about the new system, which will be programmed to administer minimal-to-moderate propofol sedation during a procedure. They’ll have an anesthesiologist on hand to assist and consult, and the person who handles sedation in a physician’s surgical team will also be trained in propofol use and how it affects the cardiovascular system.
Additionally, the company will pursue two post-approval clinical studies to gauge how the system behaves in actual clinical use. Sedasys’ clinical testing used to support its PMA application found that patients using its automated anesthesiology system recovered faster than the control group, and that patients also had less problems with oxygen desaturation than those sedated with the usual benzodiazapines or opioid drugs.
There’s a big market at stake here–as many as 15 million eligible patients in the U.S. alone, the company estimates.
Those post-approval studies will likely be closely watched. In the meantime, another kind of automated surgical system is drawing some tight scrutiny, and not the good kind. Intuitive Surgical (ISRG) is facing the first of several lawsuits alleging that it marketed its surgical robots without proper training, leading to a man’s death.
Source: J&J gains pivotal PMA for computer-aided surgical sedation device – FierceMedicalDevices http://www.fiercemedicaldevices.com/story/jj-gains-pivotal-pma-computer-aided-surgical-sedation-device/2013-05-06#ixzz2Tqg4p8ph