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THURSDAY, July 26, 2018 – A magnetic system to guide lymph node biopsies in some people with breast cancer has been approved by the US Food and Drug Administration
The Sentimag System Uses Magnetic Detection During a Sentinel Lymph Node "Sentinel lymph node biopsies are crucial in determining whether a patient's breast cancer has spread and helping the provider determine the most appropriate treatment," he said. said the agency. Dr. Binita Ashar, director of the surgical devices division of the agency. "This magnetic system that we approve today will offer patients undergoing mastectomy an option for their sentinel lymphatic biopsy procedure that does not require the injection of radioactive material."
Sentinel lymph nodes are the first lymph nodes to which cancer cells are most likely to spread from a primary tumor, the FDA said. Determining whether the cancer has spread from a primary tumor can help doctors design a treatment plan.
In clinical trials, approximately 98% of patients had the same detection rate with the Sentimag system as with the control method.
The most common side effects of the Sentimag system included breast discolouration, a cardiac disorder known as bradycardia, and an allergic reaction to magnetic materials.
The new device should not be used on sensitive people. The FDA said that the use of the device could affect the results of magnetic resonance imaging (MRI) in some cases. ) The device is produced by Endomagnetics, based in the United Kingdom
Visit the FDA to find out more.
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