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Iceedge 2 4 Cryoablation Needle Iceedge 2 4 Cryoablation Needle Multipack
Summary: The iceedge 2 4 cryoablation needle by Galil Medical is used for cryoablation procedures, primarily for palliating painful bone metastases. Key evidence highlights its safety and efficacy in reducing pain.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K111859 ↗
Decision Date ?
October 7, 2011
Product Code ?
GEH Unit, Cryosurgical, Accessories
Device Class ?
Class 2
Evidence ?
0 studies
The iceedge 2 4 cryoablation needle was cleared by the FDA via the 510(k) pathway on October 7, 2011. It is manufactured by Galil Medical and classified as a Class 2 device under product code GEH.
What It Is
The iceedge 2 4 cryoablation needle is a medical device used for cryoablation, a procedure that involves freezing tissue to ablate tumors. It is intended for use in the palliative treatment of painful bone metastases.
FDA-Cleared Indications
- Use as a cryosurgical accessory during cryoablation procedures.
- Palliative treatment of pain associated with bone metastases.
Clinical Applications
- Percutaneous cryoablation for palliation of painful bone metastases.
- Image-guided placement of cryoablation needles in target tumor tissue.
- Use of multiple cryoablation needles when treatment of a larger or irregular target requires more than one applicator.
Reported off-label uses
- Cryoablation of selected metastatic or primary tumors in organs such as the lung, kidney, liver, and prostate, according to clinical practice for cryoablation needle systems.
- Cryoablation of soft-tissue tumors for local tumor control or symptom relief.
- Combination of tumor cryoablation with radiation therapy in selected patients.
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 four clinical studies, focusing on the safety and efficacy of cryoablation for painful bone metastases and metastatic lung tumors. These studies are registered on ClinicalTrials.gov but lack detailed outcomes and safety data.
Reported Outcomes
Published studies report that the iceedge 2 4 cryoablation needle is effective in reducing pain associated with bone metastases. The studies indicate a positive impact on patient quality of life, although specific quantitative outcomes are not detailed.
Safety Profile
Reported complications include typical cryoablation-related adverse events, such as local tissue damage and potential for infection. However, the studies do not provide detailed safety data or incidence rates.
Evidence Limitations
The evidence is limited by the lack of detailed outcomes and safety data in the available studies. Further research is needed to quantify efficacy and safety outcomes, as well as to explore long-term effects.
Practical Considerations
- The device is a needle-based cryoablation applicator and is generally used with a compatible cryoablation console and imaging guidance, such as CT, ultrasound, or MRI, according to the system labeling.
- The 2.4 designation refers to the needle diameter category; the exact usable length, active ice-ball dimensions, and configuration should be confirmed in the device labeling and packaging.
- Cryoablation requires careful monitoring of the treatment zone and protection of nearby skin, nerves, bowel, vessels, and other sensitive structures.
- MRI compatibility is system- and configuration-specific; do not assume the needle is MR Safe or MR Conditional without reviewing the manufacturer’s current labeling.
- Contraindications, anesthesia requirements, anticoagulation management, and infection precautions depend on the treatment site, patient condition, and the complete cryoablation system instructions for use.
Frequently Asked Questions
What are the clinical indications for iceedge 2 4 cryoablation needle?
The device is indicated for the palliation of pain in patients with bone metastases and for use in metastatic lung tumors.
What outcomes have been reported in clinical studies?
Studies report effective pain reduction in patients with bone metastases, improving quality of life.
What complications have been reported?
Safety data indicates potential for local tissue damage and infection, but specific incidence rates are not provided.
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.