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icerod cx cryoablation needle icerod cx cryoablation needle multipack
Galil Medical
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 510K
Number K121251 ↗
Decision Date August 28, 2012
Product Code GEH
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.
Clinical Applications
Commonly used in the treatment of renal tumors and for managing abdominal pain associated with pancreatic cancer. It provides a minimally invasive option for tumor ablation.
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.
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.