FDA approves Sentimag System to guide breast cancer biopsies

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new device to guide lymph node biopsies in patients with breast cancer.

This new device is called the Magtrace and Sentimag Magnetic Localization System (Sentimag System). The FDA approved it to help health care providers determine the stage of the breast cancer and create an appropriate treatment plan.

This system is indicated for patients with breast cancer who are undergoing mastectomy, which is the surgical removal of breasts.

This device serves as an alternative to injecting radioactive materials required for a lymph node biopsy. Instead, the Sentimag System uses magnetic materials that bind to lymph nodes in tumor sites to help surgeons locate them.

Some common side effects tied to the Sentimag System included breast discoloration, slow heart rate and allergic reactions to the magnetic materials. If the magnetic materials are injected into the bloodstream, they may travel to other parts of the body and show up in MRIs.

The Sentimag System is not recommended for patients who cannot tolerate iron oxide or dextran, have an iron overload disease, or have a metal implant in their armpits or chest.

The FDA granted approval of the Sentimag System to Endomagnetics Inc.