- FDA authorized Friday, through its De Novo pathway, the marketing of two devices designed to help surgeons locate parathyroid tissue or glands, which can be difficult to see during a procedure.
- One of the devices, the Fluobeam 800, is an imaging system that avoids the need for a contrast agent through use of a light source that causes the parathyroid tissue to emit a fluorescent glow, FDA said.
- The other, the Parathyroid Detection PTeye System, uses a probe to emit fluorescent light that reacts with the tissue and includes audio and visual displays.
Thyroid cancer diagnoses in the United States are increasing at a faster rate than any other form of cancer and now account for 3.4% of all cancers, according to an article in the ASCO Post, published in partnership with the American Society of Clinical Oncology. The article authors note it is unclear whether the dramatic rise in thyroid cancer cases reflects a true increase in the incidence of the disease or is the result of increased detection due to more frequent neck imaging tests for other purposes.
The newly authorized devices for assisting surgeons in performing thyroid procedures can be used in both thyroidectomy, to remove all or part of the thyroid, and in parathyroidectomy, to remove one or more parathyroid glands.
"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, director of the surgical devices division in FDA's Center for Devices and Radiological Health, said in a press release.
Diagnoses of cancer, overactive thyroid or noncancerous enlargement of the thyroid, also known as goiter, are reasons for a thyroidectomy.
Parathyroid tissue borders the thyroid gland at the base of the neck. Overproduction of parathyroid hormone, a condition called hyperparathyroidism, is the most common parathyroid disorder and affects about 100,000 Americans each year.
The devices, Fluoptics' Fluobeam 800 and AiBiomed's PTeye System, were reviewed separately. FDA previously cleared the Fluobeam imaging system to capture fluorescent images for assessing blood flow in the evaluation of tissue perfusion.
FDA said it authorized the Fluobeam based on data from five peer-reviewed studies. One measured the rate of postoperative hypocalcemia, a drop in calcium in the blood when healthy parathyroid tissue is removed. The results showed 5% of 93 patients who had surgery with the device experienced fluctuating postoperative hypocalcemia, compared with 21% of 153 patients who had surgery without the device.
Data used to review the PTeye System found the device identified the presence of parathyroid tissue 93 percent of the time compared to histology, and identified the absence of parathyroid tissue 97% of the time compared to an expert's intraoperative visualization.
Medtronic is among the medical device companies that sell thyroid and parathyroid surgery products.