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Atricure Cryo Module System Cryoice Cryoablation Probe
Product: cryoICE Cryoablation System — all models and sizes
Summary: The AtriCure CryoICE Cryoablation Probe is a medical device used for cryoablation procedures, primarily in cardiac surgery. It is utilized by cardiothoracic surgeons to treat cardiac arrhythmias.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K142203 ↗
Decision Date ?
November 25, 2014
Product Code ?
GXH
Device Class ?
Class 2
Evidence ?
0 studies
The AtriCure CryoICE Cryoablation Probe was cleared through the FDA 510(k) pathway on November 25, 2014. Manufactured by Atricure, it is classified as a Class 2 medical device under product code GXH.
What It Is
The AtriCure CryoICE Cryoablation Probe is a specialized device designed to perform cryoablation, a procedure that uses extreme cold to destroy abnormal tissue. This device is typically used in cardiac surgery to treat arrhythmias by creating lines of scar tissue that block errant electrical signals in the heart. The probe is designed to be precise and efficient, allowing for targeted ablation while minimizing damage to surrounding tissues.
FDA-Cleared Indications
- For use in cardiac cryoablation procedures to treat cardiac arrhythmias.
- For creating lesions in cardiac tissue during surgical treatment of irregular heart rhythms.
Clinical Applications
- Surgical cryoablation for atrial fibrillation.
- Creation of cardiac ablation lines during open-heart surgery.
- Use during minimally invasive cardiac procedures when surgical treatment of an arrhythmia is indicated.
- Adjunctive cryoablation during cardiac surgery performed to manage an appropriate arrhythmia.
Practical Considerations
- The probe is intended for use by trained cardiac surgical teams familiar with surgical cryoablation and the device's instructions for use.
- Different probe configurations or sizes may be selected according to the surgical approach, target anatomy and required lesion pattern.
- The device is used with compatible cryoablation equipment and standard cardiac surgical instrumentation; exact system compatibility should be confirmed before use.
- This is a surgical device, not a standalone catheter-based treatment. Anesthesia, cardiopulmonary bypass or other operative support may be required depending on the procedure.
- MRI safety depends on the specific probe and whether it remains in the body; the device labeling should be reviewed, and an implanted or retained probe should not be assumed to be MRI safe.
Frequently Asked Questions
What is the AtriCure CryoICE Cryoablation Probe used for?
It is used for performing cryoablation procedures to treat cardiac arrhythmias by creating scar tissue that disrupts abnormal electrical pathways in the heart.
What specialties typically use this device?
Cardiothoracic surgeons primarily use this device during cardiac surgery to treat arrhythmias.
What are the FDA-cleared indications?
The device is cleared for use in cardiac cryoablation procedures to treat arrhythmias in patients requiring surgical intervention.
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.