đź“Š Evidence-Based Reference
iceedge 2 4 cryoablation needle iceedge 2 4 cryoablation needle multipack
Galil Medical
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 510K
Number K111859 ↗
Decision Date October 7, 2011
Product Code GEH
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.
Clinical Applications
This device is commonly used in clinical settings for the palliation of pain associated with bone metastases. It is also utilized in the treatment of metastatic lung tumors and in combination with radiation therapy for enhanced palliative care.
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.
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.