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xknife 5
Integra Radionics
Summary: The xknife 5 is a stereotactic radiosurgery device used primarily for treating intracranial conditions. Key evidence highlights its efficacy in treating nonvestibular schwannomas and dural carotid-cavernous sinus fistulas.
FDA Clearance Information
Pathway
510K
Number
K100417 ↗
Decision Date
April 8, 2010
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
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
The xknife 5 is a stereotactic radiosurgery device designed for precise targeting of intracranial lesions. It uses a linear accelerator to deliver focused radiation, minimizing damage to surrounding healthy tissue.
Clinical Applications
Commonly used in the treatment of intracranial nonvestibular schwannomas and dural carotid-cavernous sinus fistulas, the xknife 5 is also applied in managing large arteriovenous malformations, especially those refractory to conventional surgery.
Evidence Summary
The available literature includes 10 studies, comprising randomized controlled trials, prospective and retrospective analyses, and case series. The studies span from 2008 to 2017, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the xknife 5 is effective in treating nonvestibular schwannomas and dural carotid-cavernous sinus fistulas. It has shown promising results in fractionated stereotactic radiotherapy for large arteriovenous malformations, with improved obliteration rates.
Safety Profile
Reported complications include potential dose enhancement near metallic implants, as well as general risks associated with stereotactic radiosurgery such as radiation-induced necrosis and transient neurological deficits.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to establish long-term outcomes and to compare the efficacy of xknife 5 with other radiosurgical devices.
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.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.