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Surgical Guidance Firm Endomag has received USFDA approval for breast cancer device called Magtrace

Pre-market USFDA approval has been granted to Magtrace, the first non-radioactive dual-tracer device for lymphatic mapping in breast cancer patients manufactured by Surgical guidance firm Endomag. Currently breast cancer is treated through surgical removal of tumor and then a lymphatic mapping procedure to determine whether or not the cancer has spread to other parts of the body which usually involves the use of radioactive drugs and blue dyes having limited availability.

This also causes delays and is known to have very painful side-effects. Advantage with Magtrace as compared to current treatment is that it is non-radioactive and allows surgeons to accurately target the problematic nodes for removal without disrupting other nodes in the region. This is critical process for determining the tumor stage and thereby deciding on the treatment required.

The device is a dual tracer consisting of magnetic fluid with iron oxide particles that are designed to follow the most likely route of cancer cells when they spread across a patient’s body. The device will help US hospitals to reduce the use of radioactive tracers thereby minimizing the exposure of staff and patients to radioactivity. This will allow surgeons perform lesion localization and sentinel node biopsy with a single device. Magtrace combined with Sentimag Magnetic Localization System leads to magnetic detection during sentinel lymph node biopsy procedures to identify sentinel lymph nodes for surgical removal.

University of California, San Francisco (UCSF) professor of surgery “Michael Alvarado” is the principal investigator of the US Magtrace trial who was excited to use the Endomag’s Sentimag platform with their Magseed marker for lesion localization thereby able to being carry out both seed localization and sentinel node biopsy in one box. This in turn helped to reduce the exposure of staff and patients to radioactivity and also offered flexibility along with more options of approaching the breast cancer patients.