FDA Approves Device for Guiding SLN Biopsies in Breast Cancer
Posted: Monday, July 30, 2018
On July 24, 2018, the U.S. Food and Drug Administration (FDA) approved a magnetic device system for guiding sentinel lymph node (SLN) biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic detection during SNL biopsy procedures to identify SLNs for surgical removal.
The FDA evaluated data from a trial of 147 patients with breast cancer to compare the Sentimag System with the control method of injecting patients with blue dye and radioactive materials together and using a gamma probe to identify the SLN. The lymph node detection rate for the Sentimag System was 94.3%, whereas the control method detection rate was 93.5%. Overall, 98% of patients had the same detection rate with both the Sentimag System and the control method.
The Sentimag System comprises a sensitive magnetic sensing probe and base unit designed to detect small amounts of Magtrace, the magnetic tracer drug that is injected into breast tissue. The Magtrace particles travel to the lymph nodes and become physically trapped in them, facilitating magnetic detection of the lymph nodes. After the injection of Magtrace, the Sentimag probe is applied to the patients’ skin in areas closest to the tumor site containing the lymph nodes. The 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 SLN or nodes.
