đź“‹ FDA Reference
Icefx Cryoablation System Fprch8000-02
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 ?
510(k)
Number ?
K234002 ↗
Decision Date ?
March 13, 2024
Product Code ?
GEH Unit, Cryosurgical, Accessories
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.
FDA-Cleared Indications
- Intended for cryosurgical ablation of tissue using controlled freezing.
- Used with compatible cryoprobes and accessories for percutaneous or laparoscopic cryoablation procedures.
- Indicated for use in procedures in which image guidance is used to position cryoprobes and monitor treatment.
Clinical Applications
- Image-guided percutaneous cryoablation of selected tumors
- Laparoscopic cryoablation of selected tumors
- Cryoablation of tumors in patients for whom surgery may not be appropriate or practical
- Cryoablation of lesions in locations where controlled probe placement and monitoring are clinically appropriate
Reported off-label uses
- Cryoablation of benign soft-tissue tumors such as desmoid tumors
- Cryoablation for treatment of painful metastatic bone lesions
- Cryoablation of selected noncancerous conditions, including certain musculoskeletal or nerve-related pain conditions
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Practical Considerations
- The system requires compatible cryoprobes and accessories; probe selection depends on the target's size, shape, depth and location.
- Cryoprobes are typically placed under CT, ultrasound or MRI guidance, depending on the anatomy, local equipment and treatment plan.
- Operators must monitor the iceball and protect nearby organs, nerves, vessels and other sensitive structures from unintended freezing.
- MRI compatibility is specific to each system component, cryoprobe and accessory. Verify current Boston Scientific labeling and site-specific MRI conditions before scanning.
- Contraindications, precautions and patient-selection requirements depend on the target lesion, approach, bleeding risk, infection risk and the system's current instructions for use.
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.