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Cryoform Cryoice Cryoablation Probe
Product: cryoICE Cryoablation System — all models and sizes
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 ?
510(k)
Number ?
K152337 ↗
Decision Date ?
March 22, 2016
Product Code ?
GEH Unit, Cryosurgical, Accessories
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.
FDA-Cleared Indications
- Used to create lesions in cardiac tissue during surgical treatment of cardiac arrhythmias.
- Used as an accessory to a cryosurgical system for cardiac ablation procedures.
- The FDA-cleared device is classified under product code GEH for cryosurgical accessories.
Clinical Applications
- Creating linear or circumferential cryoablation lesions during surgical treatment of atrial fibrillation.
- Ablating targeted cardiac tissue to interrupt abnormal electrical conduction.
- Use during open cardiac surgery or selected minimally invasive cardiac procedures when surgical ablation is indicated.
- Use by trained cardiothoracic surgical teams with a compatible cryosurgical system and nitrous oxide supply.
Practical Considerations
- The probe uses nitrous oxide to produce therapeutic cooling and must be connected to compatible cryosurgical equipment.
- Correct probe positioning, tissue contact and treatment time are important for producing an effective lesion.
- The device is used in a sterile surgical setting by trained clinicians familiar with cardiac cryoablation.
- This is an invasive surgical device; patient selection and contraindications are determined by the treating surgical team.
- It is not an implanted device. MRI safety should be confirmed in the current device labeling and institutional policy before imaging after use or with any retained component.
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.