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Magtrace and Sentimag Magnetic Localization System - P160053

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This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data (SSED) and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: Magtrace™ and Sentimag® Magnetic Localization System
PMA Applicant: Endomagnetics Ltd.
Address: The Jefferys Building, Cowley Road, Cambridge, CB4 0WS, UK
Approval Date: July 24, 2018
Approval Letter: https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160053a.pdf

What is it? The Magtrace and Sentimag Magnetic Localization System is a magnetic device system used to guide lymph node biopsies in patients who are undergoing mastectomy for breast cancer. The system is a combination product that includes the Magtrace injectable magnetic tracer (a drug and a device), and the Sentimag magnetic sensing probe and base unit (device). The system assists in sentinel lymph node biopsies, which are used to determine whether the cancer has spread beyond the initial tumor into the lymph nodes, by identifying the lymph nodes draining a tumor site.

How does it work? Magtrace is a solution of iron nanoparticles coated with a carboxydextran shell. These magnetic Magtrace particles are injected into the patient's breast tissue and are absorbed into the lymph nodes. The surgeon then uses the Sentimag probe on the patients' skin near the tumor site to detect the magnetic particles located within the sentinel lymph node. That node is then removed and tested for the presence of cancer cells. Detection of the sentinel lymph nodes draining a tumor site may help direct further treatment.

When is it used? The Magtrace and Sentimag Magnetic Localization System is used in patients with breast cancer undergoing a mastectomy. The device is used to locate lymph nodes draining a tumor as part of the sentinel lymph node biopsy procedure.

What will it accomplish? Locating the first lymph nodes draining the primary tumor will help with determining further treatment for the patient. In clinical studies, Magtrace and Sentimag was found to perform as well as the traditional techniques for localizing lymph nodes (radioisotopes and blue dye), but without radiation exposure.

When should it not be used? Magtrace should not be used in patients with hypersensitivity to iron oxide or dextran compounds. It should also not be administered to any patient with iron overload disease or a metal implant in the armpit area or in the chest.

Additional information (including warnings, precautions, and adverse events): Summary of Safety and Effectiveness Data and labeling are available online.

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