SUNNYVALE, California—Xoft, Inc’s Axxent Electronic Brachytherapy System, initially FDA approved for accelerated partial breast irradiation in patients with resected early-stage breast cancer, has now received expanded FDA clearance for the treatment of other cancers or conditions where radiation therapy is indicated.
The system utilizes a miniaturized x-ray source to apply a therapeutic dose of intracavitary radiation directly to a tumor bed within the body. Unlike conventional high-dose-rate brachytherapy technologies, the Axxent system does not require radioactive isotopes, heavy shielding, or major capital equipment, and when used to treat early-stage breast cancer, can potentially reduce treatment time from 7 weeks with whole-breast external-beam radiation to 5 days, Xoft said in a press release.
“The expanded clearance for the Axxent Controller is significant in that it validates that FDA recognizes that electronic brachytherapy is a platform technology that is viable for treatment of conditions outside of the breast,” said Michael Klein, president and CEO of Xoft. “This serves as the foundation for Xoft’s expansion into new treatment areas beyond breast cancer and fuels the continued market adoption and expansion of this important technology.