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.

The FDA found that scientific evidence, including a clinical study of 17 people for testing the feasibility in accurately delivering the prescribed dose to a breast tumor while minimizing radiation to healthy tissue, supported the use of the system for this purpose with minimal radiation-induced side effects such as skin redness or erythema.

Rubenstein notes that evidence development for GammaPod will occur over time, but organizations like the American Society for Radiation Oncology (ASTRO) and the National Comprehensive Cancer Network have issued recommendations to aid clinicians in the selection of patients who may be considered for partial breast treatments instead of whole breast treatments.

“The GammaPod Stereotactic Radiotherapy System delivers a dose to a partial volume of the breast, typically the lumpectomy cavity and a small margin of surrounding tissue. “The delivery of higher doses in one or several large fractions differentiates stereotactic radiotherapy from conventional techniques,” he said. “During whole breast radiotherapy, larger radiation fields cover the entire affected breast in smaller doses per fraction over a larger number of treatments, which can range from three to seven weeks.”

The system is currently available for sale in the U.S., with Xcision working to obtain regulatory clearance in other markets.

Rad Oncology Homepage