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axxent surface applicator model 710257
Xoft
Summary: The Axxent Surface Applicator Model 710257 is an electronic brachytherapy device used primarily for tumor ablation. Key evidence highlights its dosimetric characteristics and clinical applications in intraoperative radiation therapy.
FDA Clearance Information
Pathway
510K
Number
K083734 ↗
Decision Date
February 11, 2009
Product Code
JAD
Device Class
Class 2
Evidence
0 studies
The Axxent Surface Applicator Model 710257 was cleared by the FDA via the 510(k) pathway on February 11, 2009. It is manufactured by Xoft and classified as a Class 2 medical device.
What It Is
The Axxent Surface Applicator Model 710257 is a device used in electronic brachytherapy, a form of radiation therapy that involves placing a miniature x-ray source close to the treatment area. It is designed for tumor ablation, providing localized radiation treatment.
Clinical Applications
This device is commonly used in clinical scenarios such as intraoperative radiation therapy (IORT) for early-stage breast cancer and treatment of rectal adenocarcinoma. It offers a practical solution for delivering targeted radiation therapy with minimal shielding requirements.
Evidence Summary
The available literature includes 7 studies, comprising various study types such as Monte Carlo simulations and dosimetric comparisons. The studies span from 2013 to 2025, providing insights into the device's dosimetric performance and clinical applications.
Reported Outcomes
Published studies report that the Axxent Surface Applicator Model 710257 provides effective dosimetric performance for electronic brachytherapy. The device is noted for its ability to deliver precise radiation doses, particularly in intraoperative settings. The studies highlight its potential for improving treatment outcomes in early-stage breast cancer and rectal adenocarcinoma.
Safety Profile
Reported complications include challenges related to dosimetric consistency due to variations in physics models used in Monte Carlo simulations. However, no specific adverse events or complications were detailed in the provided evidence.
Evidence Limitations
The evidence base is limited by the lack of standardized dose-to-water references and discrepancies in dosimetric models. Further research is needed to address these gaps and validate the device's performance across diverse clinical settings.
Frequently Asked Questions
What are the clinical indications for Axxent Surface Applicator Model 710257?
The device is indicated for tumor ablation, particularly in intraoperative radiation therapy for early-stage breast cancer and rectal adenocarcinoma.
What outcomes have been reported in clinical studies?
Studies report effective dosimetric performance and precise radiation delivery, improving treatment outcomes in targeted cancer therapies.
What complications have been reported?
Reported complications include dosimetric inconsistencies due to variations in Monte Carlo simulation models, but no specific adverse events were detailed.
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.