Xoft Brachytherapy System Wins Expanded Approval
Xoft, Incorporated’s Axxent Brachytherapy System received an expanded clearance from the Food and Drug Administration. This treatment system is intended to treat patients with localized, non-radioactive, isotope-free radiation treatment in clinical settings with minimal shielding, as described in the company’s news release.
The expanded clearance from the FDA allows use of the system for other malignancies or conditions where radiation therapy is an appropriate treatment option. The Axxent was initially approved by the FDA to provide accelerated treatment for patients with early stage breast cancer. For this indication, the Axxent system reduces treatment time from seven weeks, the standard with external beam radiation, to five days.
The system is an electronic, x-ray based form of radiation. The simplified platform can be used in a variety of different treatment settings. The system delivers non-radioactive radiotherapy to the disease sites while minimizing exposure to healthy tissue. The system does not require heavily shielded environments, as are necessary with external beam radiation treatments. This allows delivery of radiation therapy in many clinical settings.
Xoft also notes that applications are pending with the FDA to use Electronic Brachytherapy to treat patients with rectal and endometrial diseases.
March 21, 2008 Related topics: Radiation Oncology, Product Approval & Certification, Renal & Urology