J&J gains pivotal PMA for computer-aided surgical sedation device

May 6, 2013  | By Mark Hollmer

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