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cryoform cryoice cryoablation probe
Atricure
Summary: The CryoFORM CryoICE Cryoablation Probe is a surgical tool used by cardiothoracic surgeons to treat cardiac arrhythmias, particularly atrial fibrillation. It creates lesions to block abnormal electrical signals in the heart.
FDA Clearance Information
Pathway
510K
Number
K152337 ↗
Decision Date
March 22, 2016
Product Code
GEH
Device Class
Class 2
Evidence
0 studies
The CryoFORM CryoICE Cryoablation Probe by AtriCure was cleared via the FDA 510(k) pathway on March 22, 2016. It is classified as a Class 2 medical device under product code GEH.
What It Is
The CryoFORM CryoICE Cryoablation Probe is a medical device designed for the surgical treatment of cardiac arrhythmias, such as atrial fibrillation. It uses nitrous oxide to create continuous transmural lesions in the heart tissue, effectively blocking the propagation of abnormal electrical signals. This device is part of the cryosurgery family, which utilizes extreme cold to ablate tissue.
Clinical Applications
This device is commonly used in cardiothoracic surgery, particularly during procedures aimed at treating atrial fibrillation. It is used in hospital settings, often during open-heart surgeries or minimally invasive cardiac procedures. The primary patient population includes individuals with persistent or recurrent atrial fibrillation who have not responded to other treatments.
Indications for Use
The CryoFORM CryoICE Cryoablation Probe is indicated for patients with cardiac arrhythmias, specifically atrial fibrillation. It is used to create lesions in the heart tissue to prevent abnormal electrical signals from causing irregular heartbeats.
Practical Considerations
The probe is designed to be compatible with existing surgical techniques and equipment. It is important for clinicians to be familiar with cryoablation techniques and the specific handling of nitrous oxide-based devices. Proper sizing and positioning are crucial for effective lesion creation.
Related Literature
The linked study from 2018 examined the characteristics of the AtriCure cryoFORM cryoablation probe in the surgical treatment of cardiac arrhythmias. The study highlighted the probe's ability to create continuous transmural lesions using nitrous oxide, which is crucial for effective atrial fibrillation treatment. However, the study's limitations include a lack of long-term outcome data and a focus on device characteristics rather than patient outcomes.
Frequently Asked Questions
What is CryoFORM CryoICE Cryoablation Probe used for?
It is used for the surgical treatment of cardiac arrhythmias, particularly atrial fibrillation, by creating lesions to block abnormal electrical signals.
What specialties typically use this device?
Cardiothoracic surgeons typically use this device during cardiac surgeries, especially for treating atrial fibrillation.
What are the FDA-cleared indications?
The device is indicated for creating lesions in heart tissue to treat cardiac arrhythmias like 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.