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The United States Food and Drug Administration (FDA) has permitted marketing of 2 medical devices that can detect the location of parathyroid tissue in real time during surgical procedures, including during thyroidectomy and parathyroidectomy.
Parathyroid tissue can be difficult to distinguish visually from surrounding tissue during surgery. To preserve healthy tissue during surgical treatment of parathyroid disease, devices are used to assist in the imaging of parathyroid glands. These devices use light probes to elicit a fluorescent response from parathyroid tissue without the use of a contrast agent.
Fluoptics’ Fluobeam 800 Clinic Imaging Device and AiBiomed’s Parathyroid Detection PTeye System underwent separate FDA reviews and were both granted marketing authorization. The Fluobeam 800 was previously approved as an imaging system to assess blood flow visually for the evaluation of tissue perfusion.
For the Fluobeam 800, the FDA reviewed results from 5 studies. Of note, in one study, 93 patients had surgery using the device and 5% experienced fluctuating postoperative hypocalcemia — a biomarker for removal of healthy parathyroid tissue — compared with 21% of 153 patients whose surgical team did not use the device.
For the PTeye System, data from 1 study of 83 patients who had surgery with the device indicated that it could identify parathyroid tissue accurately compared with histology 93% of the time. In addition, PTeye was able to identify the absence of parathyroid tissue correctly compared with intraoperative visualization by an expert 97% of the time, with an overall accuracy of 96%.
Fluobeam 800 and the PTeye System were both reviewed under the FDA’s de novo premarket review pathway, which oversees approval of low- to moderate-risk novel devices. Use of these systems is not intended to replace experienced visual assessment of parathyroid tissue along with biopsy, per standard of care.
Reference
FDA permits marketing of two devices that detect parathyroid tissue in real-time during surgery [news release]. Silver Spring, MD: US Food and Drug Administration; November 2, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm624982.htm. Accessed November 2, 2018.
