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Icerod Plus 17g Cryoablation Needle Icerod Plus 17g 90 Cryoablation Needle
Summary: The icerod plus 17g cryoablation needle is a medical device used for cryoablation procedures to treat tumors. It is typically used by interventional radiologists and oncologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K110946 ↗
Decision Date ?
June 21, 2011
Product Code ?
GEH Unit, Cryosurgical, Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The icerod plus 17g cryoablation needle was cleared via the FDA 510(k) pathway on June 21, 2011. Manufactured by Galil Medical, it is classified as a Class 2 device under the product code GEH.
What It Is
The icerod plus 17g cryoablation needle is a specialized device designed for cryoablation, a procedure that uses extreme cold to destroy abnormal tissue, such as tumors. The needle delivers liquid nitrogen or argon gas to the target tissue, creating ice balls that induce cell death. This minimally invasive technique is guided by imaging technologies like ultrasound or CT scans.
FDA-Cleared Indications
- Use as an accessory to a compatible cryosurgical system for the cryoablation of tissue.
- Use for percutaneous or surgical cryoablation procedures when indicated by the compatible cryotherapy system's labeling.
- Use by trained physicians in controlled clinical settings with appropriate imaging and cryoablation equipment.
Clinical Applications
- Percutaneous image-guided cryoablation of selected tumors using a compatible cryosurgical system.
- Placement through the skin into a target lesion to create a controlled ice zone for tissue ablation.
- Use in interventional oncology procedures when cryoablation is selected instead of, or as an alternative to, surgery or other local tumor treatments.
- Use with imaging such as CT or ultrasound to guide needle placement and monitor the ablation zone.
Reported off-label uses
- Cryoablation of selected benign tumors or noncancerous masses has been described in clinical practice, but this may be outside the device's specific cleared labeling.
- Cryoablation for selected painful metastatic lesions or other symptomatic lesions has been reported in the literature and should be considered off-label unless covered by the applicable system 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.
Practical Considerations
- The device is a 17-gauge cryoablation needle; the IceRod Plus 17G 90 model has a 90 cm shaft length. Confirm the required length and needle configuration before the procedure.
- It must be used with a compatible cryosurgical console, gas supply, tubing and accessories specified by the manufacturer.
- CT, ultrasound or another appropriate imaging method is used for placement and monitoring. Imaging choice depends on the target organ, visibility and procedural requirements.
- Cryoablation can injure adjacent organs, nerves, vessels or skin if the ice zone is not monitored and controlled; treatment planning and protective techniques are required.
- The needle is intended for single use. MRI compatibility should not be assumed; verify the exact device, accessories and conditions in the current manufacturer labeling before bringing it into an MRI environment.
Related Literature
The linked study investigated the efficacy and safety of combining sintilimab, a PD-1 inhibitor, with chemotherapy and cryoablation in treating non-small cell lung cancer (NSCLC). While the abstract is not available, such studies typically assess the synergistic effects of combining immunotherapy with local tumor control methods. Limitations may include small sample sizes or lack of long-term follow-up data.
Frequently Asked Questions
What is the icerod plus 17g cryoablation needle used for?
It is used for cryoablation procedures to treat tumors by freezing and destroying cancerous tissues.
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 tumors, providing a minimally invasive treatment option for certain cancer patients.
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.