đź“‹ FDA Reference
freezor cardiac cryoablation catheter etra surgical cardiac cryoablation device max surgical cardiac cryoablation devi
Medtronic Cryocath, Lp
Summary: The Freezor Cardiac Cryoablation Catheter is a device used for cardiac ablation procedures to treat arrhythmias. It is primarily used by cardiologists in electrophysiology labs.
FDA Clearance Information
Pathway
PMA
Number
P020045 ↗
Decision Date
February 7, 2014
Product Code
LPB
Device Class
Class 3
Evidence
0 studies
The Freezor Cardiac Cryoablation Catheter was cleared by the FDA via the PMA pathway on February 7, 2014. It is manufactured by Medtronic Cryocath and classified as a Class III device.
What It Is
The Freezor Cardiac Cryoablation Catheter is a specialized medical device used to treat cardiac arrhythmias through cryoablation. It works by delivering extremely cold temperatures to targeted cardiac tissue, effectively creating lesions that disrupt abnormal electrical pathways. This device is part of a broader category of ablation devices that offer a minimally invasive alternative to surgical interventions.
Clinical Applications
This catheter is commonly used in electrophysiology labs during procedures to treat atrial fibrillation, atrial flutter, and other supraventricular tachycardias. It is typically used by electrophysiologists and interventional cardiologists. The device is suitable for adult patients with symptomatic arrhythmias that have not responded to medication.
Indications for Use
The FDA indications suggest that the device is used in facilities with additional sterilization capabilities, indicating its use in specialized settings. Clinically, it is indicated for patients with arrhythmias requiring precise ablation therapy.
Practical Considerations
The catheter is available in various sizes to accommodate different patient anatomies and is compatible with standard electrophysiology lab equipment. Proper technique involves careful mapping of cardiac tissue to ensure accurate lesion placement.
Frequently Asked Questions
What is the Freezor Cardiac Cryoablation Catheter used for?
It is used for performing cryoablation procedures to treat cardiac arrhythmias such as atrial fibrillation and atrial flutter.
What specialties typically use this device?
Electrophysiologists and interventional cardiologists typically use this device in electrophysiology labs.
What are the FDA-cleared indications?
The device is indicated for use in cardiac ablation procedures to treat arrhythmias, with specific sterilization requirements in specialized facilities.
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.