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biconite surface treatment
Bicon
Summary: Biconite surface treatment is a device used for tumor ablation. It is primarily used in oncology for treating various cancers. Key evidence highlights its potential in improving clinical outcomes in prostate cancer.
FDA Clearance Information
Pathway
510K
Number
K031568 ↗
Decision Date
November 23, 2004
Product Code
DZE
Device Class
Class 2
Evidence
0 studies
The biconite surface treatment by Bicon was cleared by the FDA through the 510(k) pathway on November 23, 2004. It is classified as a Class 2 device under product code DZE.
What It Is
The biconite surface treatment is a medical device designed for tumor ablation. It utilizes a specific surface treatment technology to target and destroy cancerous tissues. It is intended for use in clinical oncology settings.
Clinical Applications
This device is commonly used in the treatment of metastatic prostate cancer and other solid tumors. It is applied in scenarios where targeted ablation of tumor cells is required, offering a minimally invasive option for cancer management.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs, prospective, and retrospective analyses. These studies span from 2024 to 2025, providing a comprehensive overview of the device's clinical applications.
Reported Outcomes
Published studies report that the biconite surface treatment shows promise in improving outcomes for patients with metastatic prostate cancer. Notably, it has been associated with improved radiographic progression-free survival and overall survival in certain patient groups.
Safety Profile
Reported complications include typical adverse events associated with tumor ablation devices, though specific safety data from the provided evidence is limited. Further research is needed to fully characterize the safety profile of this device.
Evidence Limitations
The evidence base is limited by the small number of studies and a lack of long-term data. Further research is needed to confirm the efficacy and safety of the biconite surface treatment in diverse patient populations and cancer types.
Frequently Asked Questions
What are the clinical indications for biconite surface treatment?
The device is indicated for tumor ablation in oncology, particularly in metastatic prostate cancer.
What outcomes have been reported in clinical studies?
Studies have reported improved progression-free and overall survival in prostate cancer patients.
What complications have been reported?
Safety data is limited, but typical complications of tumor ablation devices may occur.
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.