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"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."
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 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.
The device is produced by Endomagnetics, based in the United Kingdom.
-- Scott Roberts
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