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art-plan
Therapanacea
Summary: The art-plan by Therapanacea is a clinician-facing device for adaptive radiotherapy, primarily used in cancer treatment. Key evidence highlights its potential in reducing treatment volumes and peripheral radiation dose.
FDA Clearance Information
Pathway
510K
Number
K232479 ↗
Decision Date
December 22, 2023
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The art-plan by Therapanacea was cleared via the FDA 510(k) pathway on December 22, 2023. It is classified as a Class 2 device under product code MUJ.
What It Is
The art-plan is a device designed for adaptive radiotherapy, allowing for real-time adjustments to radiation treatment plans based on patient anatomy. It is intended for use in oncology to optimize radiation delivery and minimize exposure to healthy tissues.
Clinical Applications
Commonly used in scenarios requiring precise radiation delivery, such as head and neck or prostate cancer treatments. It provides clinicians with the ability to adapt plans daily, improving treatment accuracy and patient outcomes.
Evidence Summary
The literature includes 15 studies, comprising RCTs, prospective, and retrospective analyses, published between 2023 and 2024. These studies explore the device's feasibility and dosimetric benefits in adaptive radiotherapy.
Reported Outcomes
Published studies report that the art-plan can significantly reduce treatment volumes and peripheral radiation doses in cancer patients. The device's adaptive capabilities allow for improved dose conformity and potential dose escalation while sparing adjacent organs.
Safety Profile
Reported complications include concerns about peripheral radiation dose, which studies suggest can be mitigated using low-dose CT techniques. No significant adverse events have been highlighted in the available literature.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up periods in some studies. Further research is needed to establish long-term efficacy and safety, as well as to explore its application across different cancer types.
Frequently Asked Questions
What are the clinical indications for art-plan?
The art-plan is indicated for use in adaptive radiotherapy, particularly in cancer treatments requiring precise radiation delivery, such as head and neck and prostate cancers.
What outcomes have been reported in clinical studies?
Studies report reduced treatment volumes and peripheral radiation doses, with improved dose conformity and potential for dose escalation.
What complications have been reported?
Reported complications include peripheral radiation dose concerns, which can be addressed with low-dose CT techniques. No significant adverse events have been noted.
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.