FDA clears stereotactic radiotherapy system for use in treating breast cancer

The US Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue.

Radiation therapy is an important treatment option for cancer patients. Approximately 60 percent of all cancer patients will be treated with some form of radiation therapy.During radiation therapy, tumor cells are killed when their DNA is damaged by the radiation being absorbed into them.While radiation therapy has the potential to kill tumor cells,it can also damage healthy tissue around the tumor.

The GammaPod system is intended for use in the noninvasive stereotactic delivery of a radiation dose to a portion (partial volume) of the breast in conjunction with breast conserving treatment.The GammaPod has not been shown to be as effective as whole breast radiation therapy (WBRT) and is not intended to replace WBRT.

The GammaPod system is a dedicated stereotactic radiation therapy technology designed to treat breast cancer.The GammaPod design to immobilize the breast during treatment provides the benefit of minimizing the radiation dose to the surrounding healthy tissues in the breast,heart and lungs.

The GammaPod system was reviewed through the premarket notification 510(k) pathway. A 510(k) is a premarket submission made by device manufacturers to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

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