FDA approves J&J sedation drug device

Fri May 3, 2013 9:05pm EDT

May 3 (Reuters) - U.S. regulators have approved Johnson & Johnson's Sedasys system to sedate patients during colonoscopies without the need for a physician to monitor delivery of the injectable sedating agent, the company said on Friday.

The device injects the patients who have different types of colonoscopy procedures with propofol, a minimal-to-moderate sedation agent widely used in colonoscopy procedures.

The system reduces the risks of oversedation when compared to other traditional methods, Johnson & Johnson said in a release, with 99 percent of patients recovering from the effects within 10 minutes after administration of the drug.

J&J said the system is expected to be introduced on a limited basis beginning in 2014.

The company estimates that 15 million patients in the United States are candidates for these procedures.

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.