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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 ?
510(k)
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.
FDA-Cleared Indications
- The FDA-cleared indication is external-beam radiation therapy for the treatment of patients with cancer.
- The system is intended to support three-dimensional treatment planning and image-guided delivery of therapeutic radiation.
Clinical Applications
- Image-guided external-beam radiation therapy for malignant tumors.
- Helical delivery of intensity-modulated radiation therapy (IMRT) using a rotating treatment gantry.
- CT-based patient positioning and treatment verification before or during radiation delivery.
- Treatment planning for targets requiring conformal radiation coverage while reducing dose to nearby organs.
Reported off-label uses
- Use in selected benign tumors or nonmalignant conditions has been reported for radiation therapy systems, but this is not necessarily included in the Hi-Art System's FDA-cleared labeling.
- Use for reirradiation or stereotactic-style treatment regimens may be performed at specialized centers based on clinical judgment and local protocols; these applications may be off label.
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
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.
Practical Considerations
- The Hi-Art System is a radiation therapy platform, not an implantable device or catheter, so it does not have a patient-inserted device size range.
- Treatment requires CT-based simulation, immobilization, and careful radiation planning; the patient's ability to remain still and follow breathing instructions may affect suitability.
- It uses ionizing radiation and is not MRI-based or MRI safe in the usual implant-device sense. MRI compatibility concerns may still apply to implanted devices or hardware present during treatment planning.
- Contraindications and precautions depend on the treatment plan and may include pregnancy, inability to maintain the required position, or inability to tolerate the treatment duration.
- Treatment is typically delivered over multiple outpatient sessions, although the number and duration of sessions depend on the cancer type, target location, prescribed dose, and treatment plan.
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.