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FDA clears stereotactic radiotherapy system for breast cancer
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The FDA today granted clearance to GammaPod, a noninvasive stereotactic radiotherapy system, for treating cancer in breast tissue.
The GammaPod system (Xcision Medical Systems) — reviewed under a 510(k) pathway — is intended for use in the noninvasive stereotactic delivery of radiation to a partial volume of the breast in conjunction with breast-conserving treatment.
The system uses thousands of focused beams of radiation from 36 rotating radioactive Cobalt-60 sources to deliver radiation with a vacuum-assisted cup that allows for more accurate delivery, reducing the radiation dose to surrounding healthy tissue in the heart, lung and breasts.
The FDA based this clearance on the results of a study of 17 patients, who underwent radiation treatment with GammaPod. The system was associated with minimal radiation-induced side effects, such as skin redness or erythema.
The investigators have not shown GammaPod to be as effective as whole breast radiation therapy, and the GammaPod is not intended to replace whole breast radiation therapy.
“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,” Robert Ochs, PhD, acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, said in a press release.