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News From the Food and Drug Administration
December 4, 2018

Devices Help Surgeons See Parathyroid Tissue

JAMA. 2018;320(21):2193. doi:10.1001/jama.2018.18768

Two newly approved devices will make it easier for surgeons to locate parathyroid tissue during procedures such as thyroidectomy or parathyroidectomy.

Because parathyroid tissue can be difficult to see and distinguish from other nearby tissues during surgery, the devices will provide surgeons with “valuable information to help preserve healthy tissue or to remove diseased tissue,” Binita Ashar, MD, director of the surgical devices division in the FDA’s Center for Devices and Radiological Health, said in a statement.

The Fluobeam 800 Clinic Imaging Device assists with imaging the parathyroid glands and can help surgeons visually locate parathyroid tissue during surgery. Exposure to the device’s near-infrared light causes autofluorescence in parathyroid tissue, avoiding the need for a contrast agent. The device was previously approved to aid visual assessment of blood flow to evaluate tissue perfusion, FDA officials said.

Approval of the Fluobeam 800 was based on 5 studies, including 1 that examined postoperative hypocalcemia associated with inadvertent removal of healthy parathyroid tissue. Among 93 patients who had surgery using the device, 5% had fluctuating low blood calcium levels following surgery compared with 21% of 153 patients who had surgery without the device.

Also approved was the Parathyroid Detection PTeye System, which helps detect parathyroid tissue with a probe that emits fluorescent light. When it locates parathyroid tissue, the system provides an audio and visual display indicating that tissue is present. In a study involving 81 patients who had surgery using the device, the PTeye correctly identified parathyroid tissue 93% of the time compared with histology. The device also was correct 97% of the time compared with an expert’s intraoperative visualization when it indicated that tissue was absent.