The U.S. Food and Drug Administration (FDA) has approved Endomagnetics' Magtrace and Sentimag magnetic localization system for guiding sentinel lymph node biopsies in certain patients with breast cancer.
While sentinel lymph node biopsies are currently performed on breast cancer patients after the injection of radioactive materials and/or blue dye, the Sentimag system uses magnetic detection to identify sentinel lymph nodes for surgical removal, according to the FDA. As a result, Sentimag will provide patients undergoing mastectomy with another option for their sentinel lymph node biopsy procedure that doesn't require the injection of radioactive materials, the FDA said.
The system consists of a sensitive magnetic sensing probe and base unit designed to detect small amounts of Magtrace, a magnetic tracer drug that is injected into breast tissue. The Magtrace particles become physically trapped in lymph nodes, facilitating magnetic detection of the nodes.
The Sentimag probe is then applied to the patient's skin in areas closest to the tumor site containing the lymph node. After identifying the sentinel lymph node, surgeons can make a small incision and remove it. The node is then checked by a pathologist for the presence of cancer cells, the FDA said.
