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visual-ice cryoablation system
Boston Scientific
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 510K
Number K230551 ↗
Decision Date August 8, 2023
Product Code GEH
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.
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 also used in combination therapies for conditions like non-small cell lung cancer (NSCLC).
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.
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.