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Visual-Ice Cryoablation System
Summary: The Visual-ICE Cryoablation System by Boston Scientific 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, though complete ablation of larger tumors remains challenging.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K230551 ↗
Decision Date ?
August 8, 2023
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 August 8, 2023. It is manufactured by Boston Scientific and is classified as a Class 2 medical device.
What It Is
The Visual-ICE Cryoablation System is a medical device designed to perform cryoablation, a process that uses extreme cold to destroy abnormal tissue, such as tumors. It is intended for use in the clinical setting to treat solid tumors by reducing their size or eliminating them entirely.
FDA-Cleared Indications
- Cryosurgical ablation of tissue during open and laparoscopic surgical procedures.
- Percutaneous cryoablation of tissue under imaging guidance.
- Treatment or palliation of solid tumors when used with compatible cryoprobes and accessories.
Clinical Applications
- Percutaneous image-guided cryoablation of selected solid tumors.
- Cryoablation performed during open surgical procedures.
- Cryoablation performed during laparoscopic procedures.
- Palliation of symptoms caused by selected solid tumors, such as painful tumor involvement, when consistent with the applicable labeling and clinical plan.
Reported off-label uses
- Cryoablation of selected benign tumors or noncancerous lesions in clinical settings where the device type has been described in the literature.
- Cryoablation of selected soft-tissue, musculoskeletal, or recurrent lesions beyond the specific tumor indications in the device labeling.
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. These studies span from 2023 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 eliminating small tumors. However, achieving complete ablation in larger tumors is more challenging, with cancer recurrence being a significant concern. The device has shown promise in palliating pain from bone metastases.
Safety Profile
Reported complications include challenges in achieving complete ablation of larger tumors, which may lead to cancer recurrence. Other safety data from the studies are limited, highlighting the need for further research on potential adverse events.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of comprehensive safety data. Further research is needed to explore long-term outcomes and the effectiveness of the device in larger tumor ablations.
Practical Considerations
- The system requires compatible cryoprobes, gas supply, tubing, and accessories; probe selection depends on the target size, shape, location, and desired ice-ball geometry.
- Placement is generally performed with ultrasound, CT, MRI, or another appropriate imaging modality, depending on the anatomy and procedure.
- Cryoablation can injure nearby organs, nerves, vessels, skin, or other critical structures; protective techniques and temperature monitoring may be needed.
- The system itself should not be assumed to be MRI safe or MRI conditional in every configuration. Verify the current device, probe, accessory, and room-specific MRI labeling before an MRI-guided procedure.
- Contraindications, warnings, gas requirements, probe compatibility, and reprocessing or single-use instructions should be checked in the current FDA-cleared labeling and manufacturer instructions.
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 that the device is effective in reducing tumor burden and eliminating small tumors, though complete ablation of larger tumors remains challenging.
What complications have been reported?
Reported complications include difficulty in achieving complete ablation of larger tumors, which may lead to cancer recurrence. Further 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.