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icerod plus 17g cryoablation needle icerod plus 17g 90 cryoablation needle
Galil Medical
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 510K
Number K110946 ↗
Decision Date June 21, 2011
Product Code GEH
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.
Clinical Applications
This device is commonly used in the treatment of various tumors, including those in the liver, kidneys, lungs, and bones. It is often employed in interventional radiology and oncology settings, particularly for patients who are not candidates for surgical resection. The procedure is typically performed in a hospital or outpatient surgical center.
Indications for Use
The icerod plus 17g cryoablation needle is indicated for the ablation of tumors, providing a minimally invasive option for patients with certain types of cancer. It is suitable for patients with inoperable tumors or those seeking a less invasive treatment option.
Practical Considerations
The icerod plus 17g needle is compatible with various imaging modalities for precise placement. Clinicians should be familiar with cryoablation techniques and consider the size and location of the tumor when selecting the appropriate needle size. Proper training in cryoablation procedures is essential for optimal outcomes.
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.