The approval confirms that Magtrace can still be administered either pre-operatively or intra-operatively, for patients undergoing mastectomy or lumpectomy, and is enhanced by peritumoral or subareolar injection. 

With the 1ml volume already approved in Europe*, the decision of the FDA was supported by evidence of clinical performance and the wealth of patient data collected over recent years for the reduced dosage.

This data includes papers such as the multicenter SentiDose trial (2021), which featured over 500 patients, and the randomized SUNRISE study (2020) – both of which showed non-inferiority in efficacy when compared with the previous 2ml indication and the ‘Gold Standard’ of care.

If you’d like to find out more about how this new indication will affect you, please contact your local representative, or contact us through our enquiry form.

Please note: Magtrace will continue to be sold in 2ml vials until further notice. Multi-injection use of vials is discouraged.

The Magtrace® lymphatic tracer Approved for 1ml US indication

As confirmed on April 15, 2024, the US Food and Drug Administration (FDA) has Approved a new 1ml injection volume for the Magtrace® lymphatic tracer for breast sentinel lymph node biopsy.