Cryoablation System to Be Marketed in Europe

A cryotherapy system designed to treat cardiac tachyarrhythmias has received the CE Mark. As a prerequisite, the manufacturer, CryoCath Technologies Inc. (Kirkland, Canada), also received ISO 9001 certification.

Clinical experimentation has demonstrated the safe and effective use of cryotherapy to treat a number of heart conditions, says CryoCath. The benefit is achieved by selectively destroying cellular components through intra- and inter-cellular ice formation while leaving the connective tissue intact.

The characteristics of cryotherapy make it a potentially superior treatment option for left-sided heart procedures, where heat-based therapies are limited by their safety and efficacy. The company's catheter-based cryotherapy system is called the Freezor CryoSystem. According to CryoCath, the system has the potential to treat nearly every known arrhythmia, including atrial fibrillation. CryoCath plans a focused, scaled rollout that will initially focus on the top electrophysiology centers in Europe.




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