A Medical Device Daily

Xoft (Sunnyvale, California) said that it has received expanded FDA clearance for the Axxent Electronic Brachytherapy system, a "platform" designed to deliver localized, non-radioactive, isotope-free radiation treatment in minimally-shielded clinical settings. Previously cleared for accelerated treatment of early stage breast cancer, Axxent is now cleared for use in the treatment of other cancers or conditions where radiation therapy is indicated.

Xoft said that Axxent can be used in virtually any clinical setting under the supervision of a radiation oncologist and is designed to deliver non-radioactive therapy directly to cancer sites with minimal radiation exposure to surrounding healthy tissue. This gives radiation oncologists the flexibility to deliver therapy in a broader range of clinical settings.

Axxent is designed to address a variety of oncological and non-oncological indications, Xoft said, adding that it is working to extend the use of electronic brachytherapy to endometrial and rectal indications, pending FDA clearance.

Adam Dickler, radiation oncologist at Little Company of Mary Hospital (Chicago), said, "The ability to deliver electronic X-ray-based therapy directly to the cancer site spares healthy tissue and gives us the ability to provide that therapy in a broader spectrum of clinical settings... . [W]e would expect it deliver similar benefits across a range of cancer treatments."