Radionics Xknife Hdrt System

FDA-Cleared Indications

• Delivery of high-dose radiation therapy to defined tumor sites.
• Use in stereotactic radiosurgery or stereotactic radiotherapy when precise radiation targeting is required.
• Treatment planning and delivery for localized lesions that can be accurately identified and targeted with the system.

Clinical Applications

• Stereotactic radiation treatment of selected intracranial tumors or lesions.
• Stereotactic radiation treatment of selected spinal or other localized tumors when the treatment site can be accurately planned.
• Noninvasive delivery of a focused radiation dose as an alternative to open surgery in appropriately selected patients.
• Radiation treatment planned with imaging and stereotactic localization to limit exposure to nearby normal tissue.

Reported off-label uses

• Use of stereotactic radiation techniques for selected nonmalignant intracranial lesions, such as arteriovenous malformations or certain benign tumors, may be described in clinical practice but should be evaluated under the treating radiation oncologist's judgment and applicable institutional policies.
• Use for selected recurrent or metastatic lesions may be reported in clinical practice, depending on the disease, prior radiation exposure, and treatment plan.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The system is a radiation-treatment platform rather than an implantable device; treatment requires a radiation oncology department with compatible imaging, planning, localization, and radiation-delivery equipment.
• Accurate immobilization, image registration, contouring, dose calculation, and quality assurance are essential because treatment uses a highly focused radiation dose.
• MRI safety depends on the specific components used for imaging, immobilization, and localization; the system should not be assumed to be MRI safe without reviewing the applicable component labeling.
• Patient selection depends on lesion size, location, number of targets, proximity to sensitive structures, prior radiation, and the patient's overall condition.
• Treatment may be delivered in one session or in multiple fractions, depending on the prescription and clinical plan; the equipment requires trained radiation oncologists, medical physicists, dosimetrists, and technologists.