FDA Grants Clearance to Noninvasive Stereotactic Radiotherapy System for Breast Cancer
On December 22, 2017, the U.S. Food and Drug Administration (FDA) cleared a new noninvasive stereotactic radiotherapy system intended for use in treating cancer in breast tissue.
The GammaPod system is intended for use in the noninvasive stereotactic delivery of a radiation dose to a portion of the breast in conjunction with breast-conserving treatment. During the procedure, radiation is delivered to specific areas of the breast. 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 uses thousands of focused beams of radiation from 36 rotating radioactive cobalt-60 sources in combination with a 2-layer, vacuum-assisted cup that immobilizes the breast to achieve a more accurate delivery of radiation. 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.
For this clearance, the FDA reviewed scientific evidence including a clinical study of 17 patients that tested the feasibility of accurately delivering the prescribed dose to the breast tumor while minimizing radiation to the healthy tissue. The clinical evidence supports delivering the prescribed dose to the breast tumor with minimal radiation-induced side effects such as erythema.