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modification to hi-art treatment system
Tomotherapy
Summary: The Hi-Art Treatment System modification by Tomotherapy is a device used in radiotherapy, primarily for cancer treatment. Key evidence highlights its impact on treatment delivery time and dose distribution.
FDA Clearance Information
Pathway
510K
Number
K082005 ↗
Decision Date
August 25, 2008
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Hi-Art Treatment System modification was cleared by the FDA via the 510(k) pathway on August 25, 2008. It is manufactured by Tomotherapy and classified as a Class 2 device.
What It Is
The Hi-Art Treatment System is a radiotherapy device that uses helical tomotherapy to deliver precise radiation doses to tumors. It is designed for the treatment of various cancers, allowing for adaptive radiotherapy based on intratreatment imaging.
Clinical Applications
Commonly used in the treatment of prostate cancer and non-small-cell lung cancer, the Hi-Art System is employed in scenarios requiring precise dose delivery and adaptive treatment planning. It is particularly useful in cases where tumor volume changes during therapy.
Evidence Summary
The available literature includes 8 studies, encompassing randomized controlled trials, prospective and retrospective analyses, and case series. These studies span from 2006 to 2012, focusing on treatment delivery efficiency and algorithm reliability.
Reported Outcomes
Published studies report that modifications to the Hi-Art System can decrease treatment delivery time for prostate cancer by adjusting planning parameters. The system's convolution/superposition algorithm has been validated for accuracy in heterogeneous phantoms, supporting its reliability in clinical settings.
Safety Profile
Reported complications include potential deterioration of dose distribution when optimizing for reduced delivery time. However, no significant adverse events have been highlighted in the reviewed studies.
Evidence Limitations
The evidence is limited by the small number of studies directly addressing safety and efficacy. Further research is needed to explore long-term outcomes and potential complications in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for Hi-Art Treatment System?
The Hi-Art Treatment System is indicated for use in radiotherapy for cancers such as prostate cancer and non-small-cell lung cancer, where precise dose delivery and adaptive planning are required.
What outcomes have been reported in clinical studies?
Studies have reported decreased treatment delivery time and validated algorithm accuracy, with reliable dose distribution in heterogeneous phantoms.
What complications have been reported?
Safety data indicate potential dose distribution deterioration when optimizing for delivery time, but no significant adverse events have been reported.
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.