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Icerod Cx Cryoablation Needle Icerod Cx Cryoablation Needle Multipack
Summary: The IceRod CX Cryoablation Needle is used for cryoablation of tumors. It is FDA-cleared and primarily used in renal and pancreatic cancer cases. Key studies explore its efficacy and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121251 ↗
Decision Date ?
August 28, 2012
Product Code ?
GEH Unit, Cryosurgical, Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The IceRod CX Cryoablation Needle by Galil Medical was cleared through the FDA 510(k) pathway on August 28, 2012. It is classified as a Class 2 medical device under product code GEH.
What It Is
The IceRod CX Cryoablation Needle is a medical device designed for the cryoablation of tumors. It works by delivering extreme cold to targeted tissue, causing cellular destruction. It is intended for use in oncological procedures.
FDA-Cleared Indications
- Used as an accessory in cryosurgical procedures to deliver cryogenic temperatures to targeted tissue.
- Intended for percutaneous or surgical cryoablation procedures performed under appropriate imaging or direct visualization.
- FDA product code GEH covers cryosurgical accessories, including devices used to freeze and destroy targeted tissue.
Clinical Applications
- Percutaneous cryoablation of selected tumors under CT, ultrasound, or other appropriate imaging guidance.
- Use during image-guided renal tumor cryoablation when the treating physician determines the device is appropriate.
- Use during image-guided abdominal or other soft-tissue tumor cryoablation according to the applicable device labeling and treatment plan.
Reported off-label uses
- Cryoablation of selected soft-tissue, bone, or adrenal tumors has been described in clinical practice for cryoablation needle systems, but the specific indication should be confirmed against current labeling and institutional protocols.
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
Two clinical studies are linked to this device, focusing on its use in renal and pancreatic cancer. The studies are registered on ClinicalTrials.gov, though specific details on sample size and outcomes are not provided.
Reported Outcomes
Published studies report the IceRod CX Cryoablation Needle is effective in reducing tumor size in renal cancer and alleviating abdominal pain in pancreatic cancer. However, detailed efficacy metrics are not available.
Safety Profile
Reported complications include potential damage to surrounding tissues due to the cryogenic process. Specific adverse events are not detailed in the provided studies.
Evidence Limitations
The available evidence lacks detailed outcome metrics and comprehensive safety data. Further research is needed to establish long-term efficacy and safety profiles.
Practical Considerations
- The IceRod CX is a needle-based cryoablation device; the number and placement of needles depend on tumor size, shape, location, and the planned ice-ball treatment margin.
- Use requires a compatible cryoablation console, tubing, gas supply, and accessories specified by the manufacturer; compatibility should be verified before the procedure.
- Procedures are typically performed with CT, ultrasound, or another suitable imaging method, with local anesthesia and moderate sedation or general anesthesia depending on the location and complexity.
- The needle is intended for single-use application and should be handled according to sterile technique and the manufacturer’s instructions.
- MRI compatibility and conditions should be confirmed in the current device labeling; do not assume that the needle or connected system is safe for use in the MRI environment.
Frequently Asked Questions
What are the clinical indications for IceRod CX Cryoablation Needle?
The device is indicated for the cryoablation of tumors, particularly in renal and pancreatic cancers.
What outcomes have been reported in clinical studies?
Studies suggest efficacy in tumor size reduction and pain management, but specific metrics are not detailed.
What complications have been reported?
Safety data indicate potential tissue damage, but specific complications are not detailed in the studies.
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.