WEDNESDAY, July 25, 2018 (HealthDay News) -- A magnetic system for guiding lymph node biopsies in certain people with breast cancer has been approved by the U.S. Food and Drug Administration.
The Sentimag System uses magnetic detection during a sentinel lymph node biopsy to identify certain lymph nodes for removal, the agency said in a news release.
"Sentinel lymph node biopsies are crucial for determining whether a patient's breast cancer has spread and helping the provider determine the most appropriate course of treatment," said Dr. Binita Ashar, director of the agency's Division of Surgical Devices. "This magnetic system we're approving today will offer patients undergoing mastectomy an option for their sentinel lymph biopsy procedure that does not require the injection of radioactive materials."
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Sentinel lymph nodes are the first lymph nodes to which cancer cells are most likely to spread from a primary tumor, the FDA said. Determining whether the cancer has spread from a primary tumor may help doctors devise a treatment plan.
In clinical testing, about 98 percent of patients had the same detection rate with the Sentimag System versus the control method of injecting patients with radioactive dye, the agency said.
The most common side effects of the Sentimag System included breast discoloration, a heart disorder known as bradycardia and an allergic reaction to the magnetic materials.
The new device should not be used on people who are sensitive to magnetic materials, who have "iron overload" disease or who have a metal implant in the chest or nearby areas, the FDA said.
In some cases, use of the device could affect the results of future magnetic resonance imaging (MRI) scans, the agency warned.
The device is produced by Endomagnetics, based in the United Kingdom.
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