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icepearl 2 1 cx cryoablation needle icepearl 2 1 cx prostate cryoablation kit visual-ice system iceforce 2 1 cx cryoablation needle iceforce 2 1 cx prostate cryoablation kit visual-ice system
Galil Medical
Summary: The IcePearl 2.1 CX Cryoablation Needle is used for cryoablation procedures, primarily in oncology, to treat tumors. It is utilized by interventional radiologists and oncologists.
FDA Clearance Information
Pathway
510K
Number
K152133 ↗
Decision Date
August 28, 2015
Product Code
GEH
Device Class
Class 2
Evidence
0 studies
The IcePearl 2.1 CX Cryoablation Needle by Galil Medical was cleared via the FDA 510(k) pathway on August 28, 2015. It is a Class 2 medical device.
What It Is
The IcePearl 2.1 CX Cryoablation Needle is a medical device designed for cryoablation, a technique that uses extreme cold to destroy tissue, such as tumors. The device is part of the Visual-ICE System, which provides precise control and visualization during the procedure. Cryoablation is minimally invasive and is often used when surgical resection is not feasible.
Clinical Applications
This device is commonly used in interventional radiology and oncology settings for the treatment of various tumors, including prostate and liver cancers. It is particularly useful in patients who are not candidates for surgery due to tumor location or patient comorbidities. The procedure is typically performed in a hospital or outpatient surgical center.
Indications for Use
The FDA indications for the IcePearl 2.1 CX Cryoablation Needle include the ablation of soft tissue tumors. It is particularly indicated for patients with tumors that are difficult to access surgically or when traditional surgery poses significant risks.
Practical Considerations
The IcePearl 2.1 CX is compatible with the Visual-ICE System, which provides real-time imaging guidance. The needle size and freezing cycles can be adjusted based on the tumor size and location. Proper training in cryoablation techniques is essential for optimal outcomes.
Related Literature
A study on cryoablation of hepatocellular carcinoma in woodchucks demonstrated the use of the IcePearl 2.1 CX Needle in a preclinical model. The study found that cryoablation effectively targeted liver tumors, although one subject experienced significant hemorrhage. The study's limitations include a small sample size and the use of an animal model, which may not fully translate to human clinical outcomes.
Frequently Asked Questions
What is the IcePearl 2.1 CX Cryoablation Needle used for?
It is used for cryoablation of soft tissue tumors, particularly in cases where surgical resection is not possible.
What specialties typically use this device?
Interventional radiologists and oncologists primarily use this device.
What are the FDA-cleared indications?
The device is indicated for the ablation of soft tissue tumors, especially in patients who are not candidates for surgery.
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.