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hi-art system
Tomotherapy
Summary: The Hi-Art System by Tomotherapy is a helical tomotherapy device used primarily for delivering precise radiotherapy. Key evidence highlights its efficacy in reducing tumor volume with minimal side effects.
FDA Clearance Information
Pathway
510K
Number
K042739 ↗
Decision Date
November 3, 2004
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Hi-Art System was cleared by the FDA via the 510(k) pathway on November 3, 2004. It is manufactured by Tomotherapy and classified as a Class 2 medical device.
What It Is
The Hi-Art System is a helical tomotherapy device designed for precise radiation therapy delivery. It integrates imaging and treatment capabilities to target tumors while sparing surrounding healthy tissue.
Clinical Applications
The Hi-Art System is commonly used in scenarios requiring precise radiotherapy, such as treating complex tumors in areas like the liver and colon. It is particularly useful in cases where organ motion is a concern.
Evidence Summary
The literature includes 15 studies, ranging from case reports to retrospective analyses, published between 2020 and 2023. These studies evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report significant tumor volume reduction, such as a 62% decrease in a case of sigmoid colon cancer, with no local recurrence after 6 months. The system has been compared favorably to other radiotherapy techniques in terms of dosimetric precision.
Safety Profile
Reported complications include minimal side effects, with some studies noting no adverse events. The system's precision helps in reducing toxicity to surrounding tissues.
Evidence Limitations
The evidence is limited by the small sample sizes and the retrospective nature of some studies. Further research is needed to validate findings across larger, more diverse populations.
Frequently Asked Questions
What are the clinical indications for Hi-Art System?
The Hi-Art System is indicated for precise radiotherapy in cases such as hepatocellular carcinoma and sigmoid colon cancer.
What outcomes have been reported in clinical studies?
Studies have reported significant tumor volume reduction and minimal side effects, with no local recurrence in some cases.
What complications have been reported?
Safety data indicate minimal side effects, with some studies reporting no adverse events associated with the Hi-Art System.
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.