Boston Scientific has treated the first US patient with symptomatic, drug refractory paroxysmal atrial fibrillation in ZERO AF clinical trial of its Blazer Open-Irrigated Temperature Ablation Catheter.
The Blazer Open-Irrigated Catheter features a Total Tip Cooling design which consistently cools the entire tip of the electrode while delivering radiofrequency energy into the heart tissue for restoring the continuous normal rhythm.
Texas Cardiac Arrhythmia cardiac electrophysiology executive medical director and principal investigator Andrea Natales said, "The Blazer Open-Irrigated Catheter combines an advanced tip design for irrigated ablation with the reliability of the proven Blazer platform."
The international, multi-center study, which is conducted at St David’s Medical Center,US, will enroll 472 patients to study the safety and performance of the Blazer Open-Irrigated Catheter.
St David’s Medical Center Texas Cardiac Arrhythmia Institute physician David Burkhardt said, "As expected, the Blazer Open-Irrigated catheter handled well, consistent with my previous experience using other Boston Scientific Blazer catheters."
Boston Scientific cardiac rhythm management business president Joe Fitzgerald said, "Launching this trial highlights our continued commitment to clinicians and patients through the expansion of our Electrophysiology ablation business including the high-growth segment of complex ablations."
Blazer Open-Irrigated Catheter, which is approved in CE mark countries and Canada, is an investigational device in the US and is not available for sale.