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freezor xtra surgical cardiac cryoablation device and cct 2 cardiac cardiac cryoablation cryoconsole
Cryocath Technologies
Summary: The Freezor Xtra Surgical Cardiac Cryoablation Device is used for cardiac cryoablation procedures. It is primarily indicated for the treatment of arrhythmias such as AVNRT. Key evidence supports its safety and efficacy in long-term use.
FDA Clearance Information
Pathway
510K
Number
K030303 ↗
Decision Date
April 29, 2003
Product Code
GEH
Device Class
Class 2
Evidence
0 studies
The device was cleared by the FDA through the 510(k) pathway on April 29, 2003. It is manufactured by Cryocath Technologies and classified as a Class 2 medical device.
What It Is
The Freezor Xtra Surgical Cardiac Cryoablation Device is designed to deliver cryoenergy to cardiac tissue, effectively ablating arrhythmic substrates. It is intended for use in treating cardiac arrhythmias, particularly atrioventricular nodal re-entrant tachycardia (AVNRT).
Clinical Applications
This device is commonly used in electrophysiology labs for the ablation of arrhythmias, especially in cases where radiofrequency ablation poses higher risks. It is particularly useful in treating AVNRT and atrial flutter.
Evidence Summary
The literature includes four studies, comprising randomized controlled trials and other study types, with a total sample size exceeding 500 patients. The studies span from 2005 to 2018, providing insights into long-term efficacy and safety.
Reported Outcomes
Published studies report that cryoablation using the Freezor Xtra device is effective in treating AVNRT and atrial flutter, with long-term efficacy demonstrated in follow-up studies. The device offers a safety margin due to the high resistance of the atrioventricular node to cryoenergy.
Safety Profile
Reported complications include very late recurrences of arrhythmias, as noted in long-term follow-up studies. However, the device is generally considered safe, with a favorable safety profile compared to radiofrequency ablation.
Evidence Limitations
The evidence is limited by the small number of studies and the need for more randomized controlled trials to further validate long-term outcomes. Further research is needed to explore the device's efficacy in broader patient populations.
Frequently Asked Questions
What are the clinical indications for Freezor Xtra Surgical Cardiac Cryoablation Device?
The device is indicated for the treatment of cardiac arrhythmias, particularly atrioventricular nodal re-entrant tachycardia (AVNRT) and atrial flutter.
What outcomes have been reported in clinical studies?
Studies report effective treatment of AVNRT and atrial flutter with long-term efficacy and a favorable safety profile.
What complications have been reported?
Safety data indicate very late recurrences of arrhythmias, but overall, the device is considered safe with a high safety margin.
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.