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  • Cardiac ablation catheters designed to destroy target endocardial tissue using very low temperature cooling (i.e., cryotherapy). These devices typically consist of a 10.5 Fr (3.5 mm) diameter polymeric catheter with a plastic (e.g., polyurethane) balloon near its distal tip that may be inflated to more than 20 mm in diameter. The liquid coolant circulates through the catheter and expands (i.e., vaporizes) inside the balloon at the distal end to provide the cryogenic temperature. The catheter is placed and inflated inside the left atrium of the heart and advanced to the entrance (i.e., atrium) of a pulmonary vein; a circular-pattern cryoablation is performed at the points where the balloon contacts tissue. Balloon cryotherapy ablation catheters are intended for electrical isolation of pulmonary veins in the treatment of paroxysmal atrial fibrillation; they are used as a component of a cryotherapy ablation system under fluoroscopic guidance. Also available as part of the cryogenic ablation system are small-diameter cryotherapy ablation catheters with a short distal tip. These catheters include appropriate electrodes intended for monitoring procedure results and for cryogenic point destruction of focal trigger sites.
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