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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 focal tumor ablation.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K113860 ↗
Decision Date ?
March 12, 2012
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 March 12, 2012. It is manufactured by Galil Medical and is classified as a Class 2 medical device under product code GEH.
What It Is
The Visual-ICE Cryoablation System is a medical device designed for cryoablation, a process that uses extreme cold to destroy abnormal tissue, such as tumors. It is intended for use in the treatment of solid tumors by inducing cell death through freezing.
FDA-Cleared Indications
- Cryosurgical ablation of tissue during surgical procedures.
- Cryosurgical ablation of tumors or other targeted tissue using compatible cryoprobes and imaging guidance.
- Use as an accessory system for controlled delivery of cryogenic energy during tissue ablation.
Clinical Applications
- Image-guided cryoablation of selected solid tumors.
- Percutaneous or surgical ablation when a cryosurgical approach is clinically appropriate.
- Ablation performed with compatible disposable cryoprobes under ultrasound, CT, MRI, or other appropriate imaging guidance.
- Focal destruction of targeted abnormal tissue while monitoring the developing ice ball.
Reported off-label uses
- Cryoablation of selected benign tumors or painful tumor deposits when supported by clinical judgment and available evidence.
- Palliative cryoablation for local control of symptomatic metastatic disease.
- Cryoablation of selected soft-tissue lesions outside the device labeling, depending on local practice and regulatory requirements.
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, comprising various study types such as randomized controlled trials and case series. The studies span from 2012 to 2024, providing insights into the device's efficacy and safety.
Reported Outcomes
Published studies report that the Visual-ICE Cryoablation System is effective in reducing tumor burden and achieving focal tumor ablation. It has shown promise in treating small, early-stage tumors and in combination therapies for more complex cases. However, complete ablation of larger tumors remains challenging.
Safety Profile
Reported complications include challenges in achieving complete ablation of larger tumors, which may lead to cancer recurrence. The studies did not provide detailed adverse event data, indicating a need for further research into safety outcomes.
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, more diverse patient populations.
Practical Considerations
- The system requires compatible disposable cryoprobes; probe configuration, length, active tip size, and number of probes depend on the target and planned ablation zone.
- The procedure requires imaging guidance and careful monitoring of the ice ball to protect adjacent organs, nerves, vessels, bowel, skin, and other critical structures.
- Cryoablation may be performed with local anesthesia and moderate sedation or with general anesthesia, depending on the tumor location, number of probes, and treatment approach.
- The console and cryoprobes are not automatically MRI safe; MRI use requires verification of the specific system and probe labeling, including MR Safe or MR Conditional conditions.
- Contraindications and precautions depend on the target, access route, bleeding risk, infection risk, nearby critical anatomy, and the manufacturer's current labeling.
Frequently Asked Questions
What are the clinical indications for Visual-ICE Cryoablation System?
The device is indicated for the ablation of solid tumors, particularly small, early-stage tumors, and is used in combination therapies for conditions like prostate cancer and metastatic lung tumors.
What outcomes have been reported in clinical studies?
Studies report effective reduction of tumor burden and successful focal ablation 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, potentially leading 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.