Xcision Medical Systems said that its GammaPod breast cancer treatment system has received the CE Mark.
The stereotactic radiotherapy system gained FDA clearance in 2017. The therapy differs from conventional techniques in that it delivers higher doses of more focused radiation in fewer treatments. GammaPod may also enable patients receiving whole-breast irradiation with a tumor bed “boost” to reduce the boost from several treatments to one, according to the Columbia, Md.-based company. GammaPod uses a breast cup immobilization system to minimize motion and provide high levels of accuracy for treatment planning and delivery.
Clinical trials are scheduled to begin later this year to investigate the efficacy of preoperative radiosurgery delivered in one to three treatments for patients with localized disease, according to Xcision Medical. The researchers also intend to identify patients who may be able to receive radiation alone to destroy the tumor, obviating the need for surgery.
“We are excited to bring GammaPod to the European market, where the need for more efficient, precise breast cancer radiotherapy treatments is increasing,” said Xcision founder and CEO Cedric Yu in a news release. “The ability of GammaPod to noninvasively deliver conformal radiation doses to only the affected area of the breast with the precision of stereotactic radiotherapy could certainly de-escalate care and reduce the burden of today’s protracted treatments on patients.”
Azienda Universitaria Integrata di Udine (ASUIUD) in Udine, Italy, announced last year that it would acquire GammaPod following CE marking.