Medical device manufacturer Boston Scientific has treated the first US patient with symptomatic, drug refractory paroxysmal atrial fibrillation in a clinical trial of its Blazer Open-Irrigated Temperature Ablation Catheter.
The Blazer Open-Irrigated Catheter, which features a Total Tip Cooling design, consistently cools the entire tip of the electrode during 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."
Conducted at St David's Medical Centre, US, the international, multi-centre study, ZERO AF, will enrol 472 patients to assess the safety and performance of the Blazer Open-Irrigated Catheter in treating patients with symptomatic, drug refractory paroxysmal atrial fibrillation.
The study will recruit patients from 33 various sites including the US, Europe and Asia-Pacific, according to the company.
St David's Medical Centre 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 for use in CE mark countries and Canada, is an investigational device in the US and is not available for sale.
Image: Boston Scientific's corporate headquarters in Natick, Massachusetts, US. Photo: courtesy of BostonScientific.