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hi-art system
Tomo Therapy
Summary: The Hi-Art System by Tomo Therapy is a helical tomotherapy device used primarily for precise radiotherapy treatments. Key evidence highlights its efficacy in reducing tumor volumes with minimal side effects.
FDA Clearance Information
Pathway
510K
Number
K013673 ↗
Decision Date
January 28, 2002
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The Hi-Art System was cleared by the FDA through the 510(k) pathway on January 28, 2002. It is manufactured by Tomo Therapy and classified as a Class 2 device.
What It Is
The Hi-Art System is a helical tomotherapy device designed for delivering precise radiotherapy. It combines intensity-modulated radiation therapy (IMRT) with computed tomography (CT) imaging to target tumors accurately while sparing healthy tissue.
Clinical Applications
Commonly used in the treatment of various cancers, the Hi-Art System is particularly beneficial in scenarios requiring high precision, such as head and neck cancers, prostate cancer, and pediatric tumors.
Evidence Summary
The literature includes 15 studies, comprising case reports, retrospective analyses, and comparative studies, published between 2020 and 2023. These studies explore the clinical outcomes and dosimetric comparisons of the Hi-Art System.
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's precision in targeting tumors while minimizing exposure to surrounding healthy tissues is a key finding.
Safety Profile
Reported complications include minimal to no side effects, as evidenced in the case of sigmoid colon cancer where no adverse events were noted. The device's design aims to reduce toxicity in normal 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 diverse patient populations and cancer types.
Frequently Asked Questions
What are the clinical indications for Hi-Art System?
The Hi-Art System is indicated for use in radiotherapy treatments requiring high precision, such as head and neck cancers, prostate cancer, and pediatric tumors.
What outcomes have been reported in clinical studies?
Clinical studies have reported significant tumor volume reductions and minimal side effects, with no local recurrence in some cases.
What complications have been reported?
Safety data indicate minimal to no complications, with studies highlighting the system's ability to minimize toxicity in normal tissues.
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.