The Food and Drug Administration (FDA) has cleared the GammaPod System by Xcision Medical Systems, a new noninvasive stereotactic radiotherapy system for the treatment of breast cancer.
The GammaPod System is intended for use in the noninvasive stereotactic delivery of a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment. It utilizes thousands of focused beams of radiation from 36 rotating radioactive Cobalt-60 sources combined with a 2-layer, vacuum-assisted cup that immobilizes the breast, resulting in a more targeted delivery. Immobilizing the breast also allows for a minimized radiation dose to the surrounding healthy tissues in the breast, heart, and lungs. The FDA clearance was supported by data from a study (n=17) which showed that a prescribed dose could be delivered to the breast tumor while minimizing radiation to the surrounding tissue.
Robert Ochs, PhD, from the FDA’s Center for Devices and Radiological Health, stated, “With today’s clearance, patients will have access to a treatment option that provides greater accuracy in delivering radiation therapy to breast tumors while saving surrounding breast tissue.”
The GammaPod has not been shown to be as effective as whole breast radiation therapy (WBRT) and is not intended to replace WBRT.
For more information visit FDA.gov.