đź“Š Evidence-Based Reference
Visual-Ice Cryoablation System
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 ?
510(k)
Number ?
K123865 ↗
Decision Date ?
February 6, 2013
Product Code ?
GEH Unit, Cryosurgical, Accessories
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.
FDA-Cleared Indications
- Cryoablation of solid tumors under image guidance.
- Percutaneous destruction of targeted soft-tissue or bone lesions using cryogenic energy.
- Use with compatible cryoprobes and accessories for controlled tissue freezing and thawing.
Clinical Applications
- Image-guided percutaneous cryoablation of selected solid tumors.
- Treatment of small or localized tumors when surgery is not feasible or would cause substantial morbidity.
- Cryoablation of selected painful metastatic bone lesions for local tumor control or palliation.
- Treatment of targeted tumor tissue as part of a multidisciplinary cancer treatment plan.
Reported off-label uses
- Cryoablation of selected benign tumors or nonmalignant tissue conditions has been reported in clinical practice, but this use may be outside the device labeling.
- Treatment of recurrent or oligometastatic tumors in selected organs may be performed off label depending on the anatomy, tumor type and treatment plan.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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.
Practical Considerations
- The system uses percutaneous cryoprobes placed through the skin, usually with CT, ultrasound or another suitable imaging modality for planning and monitoring.
- Probe size, number and configuration depend on the target size, shape, location and required ablation margin; multiple probes may be needed for larger lesions.
- Protective techniques may be required near skin, bowel, nerves, major vessels or other heat-sensitive structures, including hydrodissection or gas dissection when clinically appropriate.
- The system is not inherently MRI safe; MRI compatibility depends on the specific console, probe, accessory and labeling. CT or ultrasound guidance is commonly used.
- Contraindications and precautions depend on the target site and patient, including inability to safely access the lesion, uncorrectable bleeding risk, infection at the access site and structures that cannot be protected from freezing.
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.