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Endomag lymphatic mapping device receives FDA approval

Endomag magtraceSurgical guidance specialist Endomag has received premarket approval from the FDA for Magtrace, the first non-radioactive, dual-tracer for lymphatic mapping in patients with breast cancer undergoing a mastectomy. Magtrace is a liquid marker designed to follow the route that cancer cells are most likely to take when they spread from the primary tumour.

The new cancer cell tracking device is designed to help hospitals reduce their reliance on radioactive tracers and, along with Endomag’s breast lumpectomy device Magseed, to allow surgeons to perform both lesion localisation and sentinel node biopsy with the company’s Sentimag platform.

According to the American Cancer Society, about 266,000 new cases of invasive breast cancer and 65,000 cases of carcinoma in situ (the earliest form of breast cancer) will be found in the US this year, and this figure is expected to double by 2030. However, if breast cancer is detected and treated at an early stage, 99 per cent of patients are likely to be alive five years after diagnosis, but surgery is generally still needed.

For those affected, the gold standard of treatment is to remove the tumour surgically and to determine by lymphatic mapping whether the cancer has spread to other parts of the body. Typically, this involves the use of radioactive drugs and blue dyes, which are limited in their availability, can cause scheduling delays and are considered to be very painful and uncomfortable for patients. Magtrace is a non-radioactive alternative that has been developed to improve the mapping process for both patients and surgeons.

Unlike existing methods, Magtrace can be injected up to a week before surgery as the tracer is optimally sized; it is small enough to move rapidly through the breast, yet large enough to be filtered by the first draining or ‘sentinel’ lymph nodes, the ones most likely to carry cancer. The collection of Magtrace in these nodes allows the surgeon to accurately target them for removal without disrupting the rest of the nodes in the armpit. This is critical in determining the tumour stage and deciding on the patient’s best treatment pathway.

Magtrace will be exclusively distributed in North America by breast health specialist Leica Biosystems.

For more information about Endomag visit www.endomag.com

Last modified onFriday, 14 September 2018 08:38