DOTmed: FDA Greenlights Clearance of GammaPod Stereotactic Radiotherapy System
Friday, December 29, 2017
The FDA has given the green light for the clearance of a noninvasive stereotactic radiotherapy system in the treatment of breast cancer.
The government agency cleared the 510(k) premarket submission of the GammaPod Stereotactic Radiotherapy System this month, following testing of safety and feasibility in dosage delivery for breast, with exclusive manufacturing rights belonging to Xcision Medical Systems LLC.
“The GammaPod Stereotactic Radiotherapy System has been optimized for the treatment of a target within the breast,” Steve Rubenstein, vice president of marketing for Xcision Medical Systems, told HCB News. “The system includes the first and only breast stereotactic localization and immobilization device, which enables highly accurate dose delivery.”
The system is designed to deliver a radiation dose to a partial volume of the breast in conjunction with breast conserving treatment.
Equipped with 36 rotating radioactive Cobalt-60 sources, it applies focused beams of radiation from thousands of angles to a single point of the breast, in which the beams converge to form an intense focal point. A two-layer, vacuum-assisted cup immobilizes the breast to ensure a more accurate delivery and to minimize radiation dose to surrounding healthy tissues in the breast, heart and lungs.
GammaPod utilizes dose painting by moving the treatment couch through the path of the focal spot, making dose distributions highly conformal and enabling them to fall off quickly, thereby reducing the exposure of healthy tissue.
The system also offers quick and comfortable patient setup, with imaging and treatment loaders rotating patients from standing to prone position. Patients experience treatment while in prone position above the irradiation unit.
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