The US Food and Drug Administration (FDA) has cleared the GammaPod (Xcision Medical Systems), a new stereotactic radiotherapy system for use in treating breast cancer.
The GammaPod is a noninvasive stereotactic technology to be used in partial breast irradiation, as a part of breast-conserving therapy. However, the GammaPod has not been shown to be as effective as whole-breast radiation (WBRT) and is not intended to replace WBRT, said the FDA.
The scientific evidence supporting the new FDA clearance included a 17-patient clinical study, said the agency.
The small study established the GammaPod’s ability to accurately deliver the prescribed dose to the breast tumor while minimizing radiation to the healthy tissue.
“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,” said Robert Ochs, PhD, acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
The agency explains that the new device uses thousands of focused beams of radiation from 36 rotating radioactive cobalt-60 sources along with a two-layer, vacuum-assisted cup that immobilizes the breast to achieve a more accurate delivery of radiation. The design, with its focus on immobilizing the breast, minimizes radiation to the nearby healthy tissue in the breast as well as the heart and lungs.
The GammaPod system was reviewed through the premarket notification 510(k) pathway, which means that the manufacturer demonstrated that the new device is “substantially equivalent” to a legally marketed predicate device, said the FDA.
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