FDA Clears Noninvasive Stereotactic Radiotherapy System for Breast Cancer

The FDA recently cleared a new noninvasive radiotherapy system for treating patients with breast cancer, according to a press release.

Radiation therapy is a crucial component of cancer treatment, with approximately 60% of all patients receiving some form of the therapy, the FDA reported. During treatment, cancer cell DNA sustains damage from absorbing radiation; however, healthy cells can also sustain damage.

The newly-approved GammaPod system is indicated for use in the noninvasive stereotactic delivery of radiation to the affected area of the breast, in addition to breast conserving treatment, according to the release. The GammaPod system was reviewed through the premarket notification 510(k) pathway.

The FDA cautions that the GammaPod has not been proven effective as a whole breast radiation therapy and should not replace this treatment.

GammaPod harnesses thousands of focused beams of radiation from 36 rotating radioactive Cobalt-60 sources and also features a 2-layer, vacuum-assisted cup that immobilizes the breast, which assists in achieving a more targeted delivery of radiation, according to the release. Breast immobilization reduces radiation exposure to the surrounding tissues in the breast, heart, and lungs.

For the new clearance, the FDA analyzed scientific findings that included results from a clinical trial that studied the efficacy and accuracy of the GammaPod in 17 patients with breast cancer. The evidence suggested that the GammaPod can deliver the prescribed dose of radiation to the tumor with a low rate of radiation-onset adverse events, such as skin redness or erythema, according to the release.

“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,” said Robert Ochs, PhD, acting deputy director for radiological health in the Office of In Vitro Diagnostics and Radiological Health in the FDA Center for Devices and Radiological Health.