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atricure cryo module system cryoice cryoablation probe
Atricure
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 510K
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.
Clinical Applications
This device is commonly used in cardiothoracic surgery, particularly during procedures to treat atrial fibrillation and other cardiac arrhythmias. It is often employed in conjunction with other surgical techniques in both open-heart and minimally invasive settings. Patients who benefit from this device typically suffer from arrhythmias that have not responded to medication or other less invasive treatments.
Indications for Use
The FDA has cleared this device for use in cardiac cryoablation procedures, specifically for treating arrhythmias. It is intended for patients who require surgical intervention to manage irregular heart rhythms.
Practical Considerations
The AtriCure CryoICE Cryoablation Probe is compatible with standard cardiac surgical instruments and setups. It is important for clinicians to be trained in cryoablation techniques to ensure effective and safe use. The probe comes in various sizes to accommodate different patient anatomies and surgical needs.
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.