FDA OKs Devices for Parathyroid Tissue Detection During Surgery

Megan Brooks

November 02, 2018

The US Food and Drug Administration (FDA) has cleared two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy and parathyroidectomy, the agency has announced.

One is the Fluobeam 800 Clinic Imaging Device from Fluoptics and the other is the Parathyroid Detection PTeye System from AiBiomed.

For surgeons treating hyperparathyroidism or other disorders, parathyroid tissue can be visually difficult to locate and distinguish from nearby tissues during a surgery, the FDA notes in a news 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," Binita Ashar, MD, director of the Division of Surgical Devices in the FDA's Center for Devices and Radiological Health, said in the release.

According to the FDA, the Fluobeam 800 device can be used as a companion method to assist surgeons in locating parathyroid tissue visually during surgery. Parathyroid tissue emits a fluorescent glow when exposed to the device's light source, avoiding the need for a contrast agent.

In approving the Fluobeam 800 device, the FDA reviewed data from five peer-reviewed published studies, including one study that compared the rate of postoperative hypocalcemia (PH) that occurs when healthy parathyroid tissue is inadvertently removed. In 93 patients who had surgery using the device, 5% experienced fluctuating PH following surgery compared with 21% of 153 patients who had surgery without the device.

The FDA previously approved the Fluobeam device to capture and view fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion.

The Parathyroid Detection PTeye System aids in detecting parathyroid tissue during surgery by using a probe that emits fluorescence light, the FDA explains. Tissue detection is based on how the parathyroid tissue reacts to the fluorescent light. When parathyroid tissue is detected, the system provides an audio and visual display to indicate its presence.

In approving this device, the FDA reviewed data from a single-blinded study of 81 patients who had surgery using the device. Results showed that the PTeye could correctly identify the presence of parathyroid tissue as compared to histology 93% of the time and correctly identify the absence of parathyroid tissue as compared to intraoperative visualization by an expert 97% of the time, with an overall accuracy of 96%.

"Use of either device is intended to assist, not replace, experienced visual assessment in identifying the parathyroid tissue along with a biopsy to confirm thyroid tissue per standard of care," the FDA says. "The systems are not intended to be used to confirm the absence of parathyroid tissue or glands and are only to be used to assist the surgeon in locating potential parathyroid tissue or glands."

The FDA reviewed both devices through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices of a new type.

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