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nova surface applicator adpt-ondem-3dprt-bra
Adaptiiv Medical Technologies
Summary: The nova surface applicator adpt-ondem-3dprt-bra by Adaptiiv Medical Technologies is a 3D-printed device for tumor ablation and dialysis access. Key evidence highlights its use in improving dose distribution in radiation therapy.
FDA Clearance Information
Pathway
510K
Number
K241318 ↗
Decision Date
August 30, 2024
Product Code
MUJ
Device Class
Class 2
Evidence
0 studies
The device was cleared through the FDA 510(k) pathway on August 30, 2024. It is manufactured by Adaptiiv Medical Technologies and classified as a Class 2 device.
What It Is
The nova surface applicator adpt-ondem-3dprt-bra is a 3D-printed device designed for patient-specific applications in tumor ablation and dialysis access. It allows for precise dose modulation in radiation therapy.
Clinical Applications
Commonly used in gynecologic HDR brachytherapy and other radiation therapy scenarios, this device is employed to enhance dose distribution and protect organs at risk.
Evidence Summary
The available literature includes two studies from 2018 and 2021, focusing on the design and clinical applications of 3D-printed devices in radiation therapy. Study types include RCTs and case series.
Reported Outcomes
Published studies report improved dose distribution and organ-at-risk sparing in gynecologic HDR brachytherapy using patient-specific applicators. The device's versatility in creating complex radiotherapy bolus is also noted.
Safety Profile
Reported complications include limited data on long-term safety and potential issues with device fit and comfort. No significant adverse events were highlighted in the studies provided.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to validate findings across diverse patient populations.
Frequently Asked Questions
What are the clinical indications for nova surface applicator adpt-ondem-3dprt-bra?
The device is indicated for use in tumor ablation and dialysis access, particularly in enhancing dose distribution in radiation therapy.
What outcomes have been reported in clinical studies?
Studies report improved dose distribution and organ-at-risk sparing in radiation therapy applications.
What complications have been reported?
Reported complications include limited data on long-term safety and potential issues with device fit and comfort.
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.