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crf radiofrequency ablation system
Cambridge Interventional
Summary: The CRF Radiofrequency Ablation System by Cambridge Interventional is used for tumor ablation. It is FDA 510k cleared, with evidence supporting its safety and efficacy in clinical settings.
FDA Clearance Information
Pathway 510K
Number K192715 ↗
Decision Date January 7, 2020
Product Code GEI
Device Class Class 2
Evidence 0 studies
The CRF Radiofrequency Ablation System was cleared by the FDA via the 510k pathway on January 7, 2020. It is manufactured by Cambridge Interventional and classified as a Class 2 medical device.
What It Is
The CRF Radiofrequency Ablation System is a medical device designed to ablate tumors using radiofrequency energy. It is intended for use in clinical settings to target and destroy tumor tissues.
Clinical Applications
This device is commonly used in interventional oncology for the treatment of tumors. It is applicable in scenarios where minimally invasive tumor ablation is preferred over surgical resection.
Evidence Summary
The available literature includes 11 studies, comprising various study types such as RCTs and case series, conducted between 2013 and 2023. These studies evaluate the device's safety and efficacy.
Reported Outcomes
Published studies report that the CRF Radiofrequency Ablation System effectively reduces tumor size and alleviates pain in patients. The device has shown positive outcomes in both animal models and human subjects, particularly in reducing chronic pain and improving joint function.
Safety Profile
Reported complications include minor adverse events such as transient pain and localized swelling. Overall, the device has a favorable safety profile with no significant long-term complications reported in the studies.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to establish the device's efficacy across diverse patient populations and tumor types.
Frequently Asked Questions
What are the clinical indications for CRF Radiofrequency Ablation System?
The device is indicated for tumor ablation in clinical settings, particularly in interventional oncology.
What outcomes have been reported in clinical studies?
Studies have reported effective tumor size reduction and pain alleviation, with improvements in joint function.
What complications have been reported?
Safety data indicate minor adverse events such as transient pain and localized swelling, with no significant long-term complications.
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.