Magtrace® and Sentimag® Magnetic Localization System
Novel sentinel lymph node localization technique without radiation
On December 6, 2022, the U.S. Food and Drug Administration (FDA) approved PMA P160053 Supplement S002 for the Magtrace and Sentimag Magnetic Localization System. The system, made by Endomagnetics Ltd. of Cambridge, UK and Austin, TX, offers a novel method to guide sentinel lymph node biopsies in breast cancer patients. Sentinel lymph nodes are those nodes that receive drainage from a tumor and are most likely to spread cancer.
The FDA product overview notes that the system performs as well as other devices that use blue dye and a radioisotope for tracing, but does so without radiation.
About the product
The localization system has two components – Magtrace, an injectable tracer comprised of iron oxide and arboxydextran (a sugar coating) suspended in saline; and Sentimag, a magnetic localization system that displays the tracer. Magtrace is injected into the breast during a sentinel lymph node biopsy procedure and will collect in regional lymphatics and migrate to the lymph node(s). The Sentimag system detects its trace to allow clinicians to identify sentinel lymph nodes to be biopsied.
Intended use and indications
The device is intended to guide biopsies of lymph nodes for patients with breast cancer. The Magtrace injectable magnetic tracer is only intended for use with the Sentimag magnetic sensing probe and base unit.
The system is indicated for a biopsy procedure of patients undergoing a mastectomy or lumpectomy, to help determine where cancer has spread from the tumor to the patient’s lymph nodes. For lumpectomy or nipple, nipple areolar, or skin sparing procedures Magtrace is to only be injected peritumorally (around the tumor).
Contraindications
The Magtrace system should not be used in patients for whom magnetic resonance imaging (MRI) will be used for primary imaging to monitor treatment progress or for post-lumpectomy imaging. The system shall also not be used in patients with:
- hypersensitivity to iron oxide or dextran compounds
- iron overload disease, or
- metal implants in the chest or armpit areas.
The effectiveness of the system may be adversely affected by skin discoloration caused by tattoos.
More information
Please see the FDA product overview for more information about the Magtrace and Sentimag Magnetic Localization System.
