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Icefx Cryoablation System
Summary: The icefx cryoablation system is a medical device used for the cryoablation of tumors, primarily in oncology settings. It is utilized by interventional radiologists and oncologists for minimally invasive tumor treatment.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K181153 ↗
Decision Date ?
May 15, 2018
Product Code ?
GEH Unit, Cryosurgical, Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The icefx cryoablation system by Galil Medical was cleared through the FDA 510(k) pathway on May 15, 2018. It is classified as a Class 2 medical device under product code GEH.
What It Is
The icefx cryoablation system is designed to destroy targeted tissue using extreme cold. It operates by delivering cryogenic temperatures via probes inserted into the tumor, effectively inducing cell death. This minimally invasive technique is particularly beneficial for patients who are not candidates for surgery.
FDA-Cleared Indications
- Ablation of soft-tissue tumors.
- Use in patients for whom tumor ablation is clinically appropriate based on tumor location, size, and overall treatment plan.
Clinical Applications
- Image-guided cryoablation of selected soft-tissue tumors.
- Percutaneous ablation of tumors when a minimally invasive approach is appropriate.
- Treatment of tumors that may be difficult to manage with open surgery, when the procedure is consistent with the device labeling and clinical judgment.
- Cryoablation performed with compatible cryoprobes selected for the target tumor and surrounding anatomy.
Reported off-label uses
- Percutaneous cryoablation of selected renal tumors.
- Percutaneous cryoablation of selected hepatic tumors.
- Percutaneous cryoablation of selected prostate tumors.
- Cryoablation of selected osseous or soft-tissue lesions in specialized clinical practice.
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.
Practical Considerations
- The system uses cryoprobes in different sizes and configurations; probe selection depends on tumor dimensions, location, access route, and the intended ice-ball geometry.
- The procedure is generally performed with ultrasound, CT, MRI, or another appropriate imaging method, depending on the target and local practice.
- Protection of nearby organs, nerves, vessels, skin, and other sensitive structures may require hydrodissection, gas or fluid insulation, temperature monitoring, or other protective techniques.
- MRI compatibility and the conditions for use depend on the specific system components and probe configuration; users should verify the current manufacturer labeling before performing MRI-guided treatment.
- Contraindications, bleeding risk, infection risk, anesthesia requirements, and suitability for treatment should be assessed for each patient. Device use requires trained personnel and adherence to the current instructions for use.
Related Literature
The linked study explored the use of cryoablation as a focal therapy for prostate tumors located near the rectum. The study highlighted the system's precision in targeting tumors while preserving surrounding tissues. However, the study's limitations include a lack of long-term outcome data and a small sample size.
Frequently Asked Questions
What is the icefx cryoablation system used for?
It is used for the cryoablation of soft tissue tumors, particularly in oncology settings.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, especially in patients who are not surgical candidates.
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.