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01-08-2018 | FDA | News

approvalsWatch

Magnetic device helps guide breast cancer SLN biopsy

medwireNews: The US FDA has approved the use of the Magtrace and Sentimag Magnetic Localization System for the identification of sentinel lymph nodes (SLNs) during mastectomy.

The device may help to avoid the need for radioactive imaging materials in patients with breast cancer, instead using an injected magnetic tracer that can be detected using an external probe.

In a clinical trial of 147 breast cancer patients, the Sentimag System detected 94.3% of SLNs compared with 93.5% of SLNs using a conventional blue dye and radioactive material protocol; 98% of patients had the same SLN detection rate with both procedures.

Adverse events reported include transient breast discoloration, bradycardia and risk of allergy, and the magnetic system is contraindicated in patients with hypersensitivity to iron oxide or dextran, iron overload disease, or a metal implant in the axilla or chest.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2018 Springer Healthcare part of the Springer Nature group

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