📊 Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Delivery of image-guided, intensity-modulated external-beam radiation therapy.
- Helical delivery of radiation dose to defined treatment volumes using computerized treatment planning.
- Use of integrated imaging to support patient positioning and treatment verification.
Clinical Applications
- External-beam radiation treatment of malignant tumors when prescribed by a radiation oncology team.
- Image-guided intensity-modulated radiotherapy for treatment volumes that require conformal dose delivery.
- Helical tomotherapy treatment planning and delivery based on computed tomography imaging.
- Verification of patient positioning before or during radiation treatment.
Reported off-label uses
- Clinical use for selected benign tumors or other nonmalignant conditions has been reported for radiotherapy systems, but these applications depend on separate clinical judgment and are not necessarily included in the device labeling.
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 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.
Practical Considerations
- This is a treatment-delivery system rather than an implanted device or catheter; it does not have a patient-specific implant size range.
- Treatment requires simulation imaging, computerized planning, accurate patient positioning, and quality assurance before radiation is delivered.
- The system uses ionizing radiation and is not an MRI scanner or an MRI-compatible implant; MRI safety questions concern the patient, immobilization equipment, and any implanted devices separately.
- Use may be limited by the patient's ability to remain positioned during imaging and treatment, the target's location and motion, and the radiation dose constraints for nearby organs.
- Treatment duration and number of sessions vary with the cancer, treatment plan, and prescription; radiation oncology teams determine whether helical tomotherapy is appropriate.
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.