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icesphere 1 5 cx cryoablation needle
Galil Medical
Summary: The IceSphere 1.5 CX Cryoablation Needle is a medical device used for cryoablation procedures to treat tumors. It is commonly used by interventional radiologists and oncologists.
FDA Clearance Information
Pathway
510K
Number
K181741 ↗
Decision Date
July 30, 2018
Product Code
GEH
Device Class
Class 2
Evidence
0 studies
The IceSphere 1.5 CX Cryoablation Needle received FDA clearance through the 510(k) pathway on July 30, 2018. Manufactured by Galil Medical, it is a Class 2 medical device.
What It Is
The IceSphere 1.5 CX Cryoablation Needle is a specialized tool designed for the cryoablation of tumors. It works by delivering extreme cold to targeted tissues, causing cellular destruction through freezing. This minimally invasive technique is often used in oncology to treat solid tumors by inducing cell death while preserving surrounding healthy tissue.
Clinical Applications
This device is primarily used in interventional radiology and oncology settings for the treatment of various tumors, including those in the liver, kidneys, and lungs. It is suitable for patients who are not candidates for surgical resection or who prefer a less invasive procedure. The needle is often used in outpatient settings or during short hospital stays, allowing for quicker recovery times.
Indications for Use
The FDA indications for the IceSphere 1.5 CX Cryoablation Needle include the treatment of solid tumors through cryoablation. It is intended for patients with tumors that are accessible via percutaneous routes and where freezing is deemed an appropriate treatment modality.
Practical Considerations
The IceSphere 1.5 CX Cryoablation Needle is available in various sizes to accommodate different tumor sizes and locations. It is compatible with imaging guidance systems, which assist in precise placement and monitoring during the procedure. Clinicians should be trained in cryoablation techniques to ensure optimal outcomes.
Frequently Asked Questions
What is IceSphere 1.5 CX Cryoablation Needle used for?
It is used for the cryoablation of solid tumors, providing a minimally invasive treatment option for patients.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in the treatment of tumors.
What are the FDA-cleared indications?
The device is cleared for the treatment of solid tumors through cryoablation, particularly in patients where surgical options are limited.
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.