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cryocor cryoablation system
Boston Scientific
Summary: The CryoCor Cryoablation System by Boston Scientific is used for the ablation of isthmus-dependent right atrial flutter in adults. Key evidence highlights its efficacy in producing permanent cavotricuspid isthmus block with minimal procedural pain.
FDA Clearance Information
Pathway
PMA
Number
P050024 ↗
Decision Date
August 1, 2007
Product Code
OAD
Device Class
Class 3
Evidence
0 studies
The CryoCor Cryoablation System received FDA premarket approval (PMA P050024) on August 1, 2007. It is manufactured by Boston Scientific and classified as a Class III medical device.
What It Is
The CryoCor Cryoablation System is a medical device designed for cryoablation, a procedure that uses extreme cold to destroy tissue. It is specifically intended for the ablation of isthmus-dependent right atrial flutter in patients aged 18 years or older.
Clinical Applications
This device is commonly used in clinical settings for patients with isthmus-dependent right atrial flutter, a type of supraventricular tachycardia. It provides an alternative to radiofrequency ablation, particularly in cases where minimizing procedural pain is a priority.
Evidence Summary
The available literature includes six studies, comprising randomized controlled trials and prospective studies, conducted between 2003 and 2005. These studies evaluate the efficacy and safety of the CryoCor Cryoablation System in treating atrial flutter and other arrhythmias.
Reported Outcomes
Published studies report that the CryoCor Cryoablation System is effective in achieving permanent cavotricuspid isthmus block in patients with atrial flutter. One study highlighted the reduced pain perception compared to radiofrequency ablation, while another confirmed its efficacy in pulmonary vein isolation without risk of stenosis.
Safety Profile
Reported complications include minimal procedural pain and a low incidence of adverse events. The studies emphasize the safety profile of cryoablation, particularly in comparison to radiofrequency ablation, which is associated with higher pain levels.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of long-term follow-up data. Further research is needed to evaluate the long-term efficacy and safety of the CryoCor Cryoablation System, as well as its application in broader patient populations.
Frequently Asked Questions
What are the clinical indications for CryoCor Cryoablation System?
The device is indicated for the ablation of isthmus-dependent right atrial flutter in patients 18 years of age or older.
What outcomes have been reported in clinical studies?
Studies report effective permanent cavotricuspid isthmus block and reduced pain perception compared to radiofrequency ablation.
What complications have been reported?
Reported complications include minimal procedural pain, with a generally favorable safety profile compared to other ablation techniques.
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.