FDA authorizes marketing of parathyroid tissue detection devices

The FDA will allow the marketing of the Fluobeam 800 Clinic Imaging Device and the Parathyroid Detection PTeye System, which are two devices used to identify parathyroid tissue during surgery.

“For some patients with parathyroid disease, treatment may mean a surgical procedure,” Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health, said in an FDA press release. “Real-time identification of parathyroid tissue during surgery can provide surgeons with valuable information to help preserve healthy tissue or to remove diseased tissue.”

Both devices use fluorescent light to identify and locate parathyroid tissue during procedures such as thyroidectomies and parathyroidectomies.

The Fluobeam 800 Clinic Imaging Device provides a light source that causes parathyroid tissue to take on a fluorescent glow and become distinguishable from other tissues. The FDA came to its decision by reviewing five peer-reviewed studies concerning the Fluobeam 800 device. In one study, 93 patients had surgery using the device. Of these patients, 5% had fluctuating postoperative hypocalcemia. In 153 patients who had surgery without the device, 21% developed postoperative hypocalcemia.

In the Parathyroid Detection PTeye System, a probe that gives off fluorescent light interacts with the parathyroid tissue, which will react differently to the light than other tissue. A study used for evaluation by the FDA showed the Parathyroid Detection PTeye System had an overall accuracy of 96%.

Both devices are meant to be used as assistive tools in concert with visual assessment and biopsy to identify thyroid and parathyroid tissues, the FDA noted in the release.

Reference:

www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624982.htm