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icefx cryoablation system
Galil Medical
Summary: The icefx cryoablation system is a medical device used for the cryoablation of tumors, primarily in oncology settings. It is utilized by interventional radiologists and oncologists for minimally invasive tumor treatment.
FDA Clearance Information
Pathway 510K
Number K181153 ↗
Decision Date May 15, 2018
Product Code GEH
Device Class Class 2
Evidence 0 studies
The icefx cryoablation system by Galil Medical was cleared through the FDA 510(k) pathway on May 15, 2018. It is classified as a Class 2 medical device under product code GEH.
What It Is
The icefx cryoablation system is designed to destroy targeted tissue using extreme cold. It operates by delivering cryogenic temperatures via probes inserted into the tumor, effectively inducing cell death. This minimally invasive technique is particularly beneficial for patients who are not candidates for surgery.
Clinical Applications
Commonly used in oncology, the icefx system is employed for the ablation of tumors in organs such as the prostate, liver, and kidneys. It is particularly useful in cases where tumors are located near sensitive structures, allowing precise targeting while sparing surrounding tissues. This device is often used in outpatient settings or specialized cancer treatment centers.
Indications for Use
The FDA has cleared the icefx system for the ablation of soft tissue tumors. It is particularly indicated for patients with tumors that are difficult to access surgically or for those who prefer a less invasive treatment option.
Practical Considerations
The icefx system is compatible with various probe sizes, allowing customization based on tumor size and location. Clinicians should be trained in cryoablation techniques to optimize outcomes and minimize complications.
Related Literature
The linked study explored the use of cryoablation as a focal therapy for prostate tumors located near the rectum. The study highlighted the system's precision in targeting tumors while preserving surrounding tissues. However, the study's limitations include a lack of long-term outcome data and a small sample size.
Frequently Asked Questions
What is the icefx cryoablation system used for?
It is used for the cryoablation of soft tissue tumors, particularly in oncology settings.
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 soft tissue tumors, especially in patients who are not surgical candidates.
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.