The FDA has approved Endomagnetics Inc.’s magnetic device system for guiding lymph node biopsies in breast cancer patients undergoing a mastectomy. The Sentimag Magnetic Localization System detects magnetic seeds or a magnetic drug to identify the specific lymph nodes to which cancer cells are most likely to spread from the original tumor.
A biopsy of these sentinel lymph nodes can help clinicians identify, remove and examine lymph nodes to determine whether cancer cells are present.
“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 Binita Ashar, MD, director of the Division of Surgical Devices in the FDA’s Center for Devices and Radiological Health in an agency statement. “Currently, a sentinel lymph node biopsy is performed after injection of radioactive materials and/or blue dye. 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.”