The FDA has approved a magnetic device system used for guiding sentinel lymph node biopsies in breast cancer patients undergoing a mastectomy. The solution, Sentimag, is manufactured by U.K.-based Endomag.
“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,” Binita Ashar, MD, director of the division of surgical devices in the FDA’s Center for Devices and Radiological Health, said in a prepared 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.”
Testing a breast cancer patient’s sentinel lymph nodes helps providers know if the cancer has spread from the breasts to other parts of their body. Negative biopsy results indicate the cancer has not spread to other lymph nodes, but a positive result means the cancer may have already spread to other organs.
The newly approved solution uses magnetic materials to help guide the surgeon to where they need to make a small incision and remove the lymph node in question. The FDA studied data from 147 breast caner patients to test its effectiveness. Its lymph node detection rate of 94.3 percent was slightly more than the control method of injecting patients with blue dye and radioactive materials.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.