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atricure cryoice cryo-ablation probe cryo2 aatricure cryoice cryosphere cryoablation probe cryos cryos-l
Atricure
Summary: The AtriCure CryoICE Cryo-Ablation Probe is a medical device used for cryoablation procedures, primarily in cardiac surgery. It is utilized by cardiac surgeons to treat arrhythmias by freezing tissue.
FDA Clearance Information
Pathway 510K
Number K200697 ↗
Decision Date December 23, 2020
Product Code GXH
Device Class Class 2
Evidence 0 studies
The AtriCure CryoICE Cryo-Ablation Probe was cleared via the FDA 510(k) pathway on December 23, 2020. Manufactured by AtriCure, it is classified as a Class II device under product code GXH.
What It Is
The AtriCure CryoICE Cryo-Ablation Probe is a surgical instrument designed for cryoablation, a process that uses extreme cold to destroy abnormal tissue. The device operates by delivering cold energy to targeted areas, effectively freezing and disrupting the function of the tissue. This is particularly useful in cardiac surgery to treat arrhythmias by creating lines of scar tissue that block abnormal electrical pathways in the heart.
Clinical Applications
This device is commonly used in cardiac surgery settings, particularly during procedures to treat atrial fibrillation and other arrhythmias. Cardiac surgeons utilize it to perform cryoablation, which is often part of a broader surgical strategy to restore normal heart rhythm. The probe is suitable for use in both adult and pediatric populations, depending on the specific clinical scenario.
Indications for Use
The FDA indications suggest that this device is intended for use in patients requiring ablation of cardiac tissue to treat arrhythmias. It is particularly indicated for creating lesions in the heart to manage conditions like atrial fibrillation.
Practical Considerations
The AtriCure CryoICE Cryo-Ablation Probe is typically available in various sizes to accommodate different surgical needs. It is compatible with standard cryoablation systems and requires careful handling to ensure precise application of cold energy. Surgeons should be familiar with the technique of cryoablation to optimize outcomes.
Frequently Asked Questions
What is the AtriCure CryoICE Cryo-Ablation Probe used for?
It is used for cryoablation procedures in cardiac surgery to treat arrhythmias by freezing and disrupting abnormal tissue.
What specialties typically use this device?
Cardiac surgeons primarily use this device during surgical procedures to manage heart arrhythmias.
What are the FDA-cleared indications?
The device is indicated for use in the ablation of cardiac tissue to treat arrhythmias, such as atrial fibrillation.
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.