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visual-ice cryoablation system
Galil Medical
Summary: The Visual-ICE Cryoablation System by Galil Medical is a device used for the ablation of solid tumors. It is primarily used to reduce tumor burden and eliminate small, early-stage tumors. Key evidence highlights its effectiveness in tumor ablation but notes challenges in complete ablation of larger tumors.
FDA Clearance Information
Pathway 510K
Number K123865 ↗
Decision Date February 6, 2013
Product Code GEH
Device Class Class 2
Evidence 0 studies
The Visual-ICE Cryoablation System received FDA clearance through the 510(k) pathway on February 6, 2013. It is manufactured by Galil Medical and classified as a Class 2 device under product code GEH.
What It Is
The Visual-ICE Cryoablation System is a medical device designed for the cryoablation of solid tumors. It operates by freezing tissue to induce cell death, thereby reducing tumor size or eliminating small tumors. It is intended for use in clinical settings for tumor ablation procedures.
Clinical Applications
Common clinical scenarios for the Visual-ICE Cryoablation System include the treatment of small, early-stage tumors and the palliation of painful bone metastases. It is often used when surgical resection is not feasible or as an adjunct to other therapies.
Evidence Summary
The available literature includes six studies, with a mix of randomized controlled trials and other study types. The studies span from 2013 to 2024, focusing on the device's efficacy and safety in various clinical contexts.
Reported Outcomes
Published studies report that the Visual-ICE Cryoablation System is effective in reducing tumor burden and eliminating small tumors. However, achieving complete ablation in larger tumors remains challenging. The system has shown promise in palliating pain from bone metastases and potentially in combination therapies for conditions like NSCLC.
Safety Profile
Reported complications include challenges in achieving complete ablation of larger tumors, which may lead to cancer recurrence. The studies reviewed did not provide detailed safety data, indicating a need for further research into potential adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety data. Further research is needed to explore long-term outcomes and the effectiveness of the device in larger tumor ablation. Additionally, more comprehensive studies on safety and adverse events are necessary.
Frequently Asked Questions
What are the clinical indications for Visual-ICE Cryoablation System?
The Visual-ICE Cryoablation System is indicated for the ablation of solid tumors, particularly small, early-stage tumors, and for the palliation of painful bone metastases.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective tumor burden reduction and elimination of small tumors, with challenges noted in the complete ablation of larger tumors.
What complications have been reported?
Reported complications include difficulties in achieving complete ablation of larger tumors, which may lead to cancer recurrence. Detailed safety data is limited.
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.