Introduction to the cryoICE® System
The AtriCure cryoICE® system cryoablation probe is a sterile, single-use medical device designed for the precise treatment of cardiac arrhythmias. It utilizes cryogenic nitrous oxide (N2O) to achieve controlled temperatures, creating cryoablated lesions that block electrical conduction pathways in the heart.
Key Features and Purpose
This probe is intended for use by certified medical professionals in cardiothoracic surgical procedures. Its primary purpose is to restore normal sinus rhythm by effectively treating conditions such as atrial fibrillation, atrial flutter, and atrial tachycardia. The system includes the probe and a forming tool for shaping the malleable section of the probe to suit specific procedural needs.
Important Information
Users must carefully read and follow all instructions, warnings, and cautions provided in this document to ensure safe and effective operation and to prevent device damage or patient injury. The system is designed for use with the AtriCure Cryo Module (ACM) and requires proper training for its application.
For detailed safety and performance information, users are directed to the Cryo Summary of Safety and Clinical Performance (SSCP) available in the European database on medical devices (Eudamed) at https://ec.europa.eu/tools/eudamed.
