(RxWiki News) The US Food and Drug Administration (FDA) has approved a new radiation therapy system to treat breast cancer.
This new approval is called the GammaPod system. It's a stereotactic radiotherapy system to treat breast cancer. And it doesn't require surgery.
“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 Dr. Robert Ochs, of the FDA's Office of In Vitro Diagnostics and Radiological Health, in a press release.
Radiation therapy is considered a critical treatment option for patients with cancer. In fact, an estimated 60 percent of all cancer patients will be treated with some form of radiation therapy.
In radiation therapy, tumor cells are killed when their DNA is damaged by the radiation — and this damage occurs in the healthy tissue that surrounds the tumor.
The GammaPod system enables the delivery of a radiation dose to a portion (partial volume) of the breast and enables breast-conserving treatment. In other words, this new system allows radiation to be delivered to specific areas of the breast. This is possible because the system's design helps immobilize the breast during treatment. As a result, it minimizes the radiation exposure to surrounding healthy breast tissues, as well as to the surrounding organs, such as the heart and lungs.
The GammaPod system has not been shown to work as well as whole breast radiation therapy (WBRT). The system is not intended to replace WBRT, according to the FDA.
The clearance of the GammaPod system was a result of the review of a clinical study that delivered the prescribed dose to the breast tumor in 17 patients. The GammaPod system was reviewed through the premarket notification 510(k) pathway. The FDA granted the device's clearance to Xcision Medical Systems, LLC.