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icefx cryoablation system fprch8000-02
Boston Scientific
Summary: The icefx cryoablation system is a medical device used for cryoablation procedures, primarily in oncology. It is utilized by interventional radiologists and oncologists for treating tumors.
FDA Clearance Information
Pathway 510K
Number K234002 ↗
Decision Date March 13, 2024
Product Code GEH
Device Class Class 2
Evidence 0 studies
The icefx cryoablation system by Boston Scientific was cleared via the FDA 510k pathway on March 13, 2024. It is a Class 2 device under product code GEH.
What It Is
The icefx cryoablation system is a device designed to perform cryoablation, a minimally invasive procedure that uses extreme cold to destroy abnormal tissue, such as tumors. The system delivers controlled freezing to the targeted area, causing cell death and tissue necrosis. This technique is particularly useful in treating tumors that are difficult to access or near sensitive structures.
Clinical Applications
The icefx cryoablation system is commonly used in oncology for the treatment of various types of tumors, including prostate, kidney, and liver tumors. It is often employed in interventional radiology settings, where precise imaging guidance is available. The device is suitable for patients who are not candidates for surgical resection or those with tumors located in challenging anatomical locations.
Indications for Use
The FDA indications for the icefx cryoablation system include its use in the ablation of tumors. It is intended for patients with tumors that are accessible via percutaneous or laparoscopic approaches, providing an alternative to surgical intervention.
Practical Considerations
The icefx cryoablation system is typically compatible with standard imaging modalities such as ultrasound, CT, or MRI for guidance. Clinicians should consider the size and location of the tumor when selecting cryoprobe size and placement technique to ensure effective ablation.
Related Literature
The linked study explored the use of cryoablation as a focal therapy for prostate tumors located near the rectum. Although the abstract is not available, the study likely investigated the safety and efficacy of the procedure in this challenging anatomical area. Limitations may include a small sample size or lack of long-term follow-up data.
Frequently Asked Questions
What is the icefx cryoablation system used for?
It is used for the cryoablation of tumors, providing a minimally invasive treatment option for various cancers.
What specialties typically use this device?
Interventional radiologists and oncologists commonly use this device in oncology settings.
What are the FDA-cleared indications?
The device is indicated for the ablation of tumors, offering an alternative to surgical resection for patients with accessible tumors.
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.