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FDA Approves Novel Localization System for Sentinel Lymph Node Biopsy

July 27, 2018

On July 24, 2018, the Food and Drug Administration (FDA) granted a premarket approval for the Magtrace and Sentimag Magnetic Localization System (Endomagnetics Inc.) to assist in localizing lymph nodes draining a tumor site, as part of a sentinel lymph node biopsy procedure, in patients with breast cancer undergoing a mastectomy.

Current care options for a sentinel lymph node biopsy require injection of radioactive materials and/or blue dye. The Sentimag System uses magnetic materials to guide the sentinel lymph node biopsy procedure. The system is comprised of a magnetic sensing probe and base unit designed to detect small amounts of Magtrace, the magnetic tracer that is injected into breast tissue. The Magtrace particles travel to lymph nodes and become physically trapped in them, facilitating magnetic detection of the lymph nodes. Following the injection of Magtrace, the Sentimag probe is applied to the patients’ skin in areas closest to the tumor site containing the lymph nodes. Sensing of the magnetic particles is indicated by changes in audio and visual alerts from the base unit, enabling the surgeon to move the hand-held probe around the area of the lymph nodes, and locate the sentinel lymph node or nodes (if there are more than one). The surgeon then makes a small incision and removes the node, which is examined by a pathologist for the presence of cancer cells.

A negative sentinel lymph node biopsy result suggests that cancer has not spread to nearby lymph nodes. A positive result may indicate that cancer is present in the sentinel lymph node and may be present in other nearby lymph nodes and possibly other organs. This information can help a doctor determine the stage of the cancer and develop an appropriate treatment plan.

 

Food and Drug Administration (FDA). FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer [news release]. July 24, 2018. Available at: click here. Accessed July 27, 2018.