Xknife 5
Integra Radionics
FDA Clearance Information
The xknife 5 was cleared by the FDA through the 510(k) pathway on April 8, 2010. It is manufactured by Integra Radionics and classified as a Class 2 device.
What It Is
FDA-Cleared Indications
- Use for stereotactic radiosurgery of intracranial lesions when precise, focused radiation treatment is indicated.
- Use with image-guided treatment planning and radiation delivery for selected intracranial targets.
- FDA clearance was granted through the 510(k) pathway under product code MUJ; the supplied record does not include the device-specific FDA indications statement.
Clinical Applications
- Stereotactic radiation treatment of selected intracranial tumors and other lesions.
- Focused radiation treatment of skull-base lesions, including selected nonvestibular schwannomas when included in the treatment plan.
- Stereotactic radiosurgery planning and delivery for selected intracranial vascular abnormalities when covered by the applicable system labeling and clinical protocol.
- Image-guided radiation delivery designed to limit exposure to nearby healthy brain tissue.
Reported off-label uses
- Treatment of selected large or surgically difficult arteriovenous malformations when conventional surgery is not appropriate.
- Treatment of dural carotid-cavernous sinus fistulas in selected clinical settings.
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.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- This is a treatment system rather than an implant; it does not have an implanted size or a permanent service life in the patient.
- Treatment requires stereotactic imaging, target delineation, radiation planning, and verification before radiation is delivered.
- The patient may require a stereotactic frame or frameless immobilization system, depending on the treatment protocol.
- MRI safety depends on the specific immobilization, localization, and accessory components used; each component should be checked separately against its labeling.
- Suitability depends on lesion size, location, prior radiation, overall health, and the risks of radiation, surgery, medication, or observation.
Frequently Asked Questions
What are the clinical indications for xknife 5?
The xknife 5 is indicated for the treatment of intracranial nonvestibular schwannomas, dural carotid-cavernous sinus fistulas, and large arteriovenous malformations.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective treatment outcomes for nonvestibular schwannomas and dural carotid-cavernous sinus fistulas, with improved obliteration rates for large arteriovenous malformations.
What complications have been reported?
Safety data from evidence indicate complications such as dose enhancement near metallic implants and risks of radiation-induced necrosis and transient neurological deficits.