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Atricure Cryoice Cryo-Ablation Probe CRYO2 Aatricure Cryoice Cryosphere Cryoablation Probe Cryos Cryos-L
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 ?
510(k)
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.
FDA-Cleared Indications
- Ablation of cardiac tissue during cardiac surgery to treat atrial fibrillation and other cardiac arrhythmias.
- Creation of linear or focal cryoablation lesions in the heart to interrupt abnormal electrical conduction pathways.
- Use by trained cardiac surgeons with a compatible AtriCure cryoablation system according to the device labeling.
Clinical Applications
- Surgical cryoablation as part of a maze or maze-type procedure for atrial fibrillation.
- Creation of ablation lines on the atria during open-heart surgery.
- Treatment of selected cardiac arrhythmias when surgical ablation is performed with another indicated cardiac procedure.
- Application of controlled cold energy to cardiac tissue to create therapeutic scar lines that block abnormal electrical signals.
Practical Considerations
- The probe must be used with the compatible cryoablation console and accessories specified in the manufacturer's instructions.
- Probe configurations and working lengths may vary by model; the surgical team selects the configuration based on the anatomy and planned lesion set.
- Cryoablation requires direct placement of the probe on the intended tissue and careful control of contact, duration, and location.
- This is a surgical device, not an implanted device; it is removed after the lesion is created and is not intended to remain in the body.
- MRI safety depends on the specific probe and system and on whether the device is present; consult the current labeling rather than assuming MRI compatibility.
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.