Boston Scientific Corporation (NYSE: BSX) today announced the first use of the Blazer® Open-Irrigated Catheter in the U.S. as part of the BLOCk-CTI clinical trial. BLOCk-CTI is a prospective, randomized trial evaluating the safety and effectiveness of the Blazer Open-Irrigated Catheter in patients with sustained or recurrent Type 1 atrial flutter. The trial plans to enroll up to 240 patients at 22 sites in the U.S.
Atrial flutter is an arrhythmia associated with the right atrium of the heart that affects nearly 1 million people in the U.S. Patients with Type 1 atrial flutter may exhibit symptoms including palpitations, shortness of breath, fatigue, lightheadedness and fainting. Catheter ablation has become a first-line treatment approach for patients with recurrent Type 1 atrial flutter, demonstrating more successful short- and long-term outcomes compared to anti-arrhythmic drugs.
"The Blazer Open-Irrigated Catheter combines a new technique for irrigated ablation with the reliability of the proven Blazer platform," said Emile Daoud, M.D., Section Chief, Cardiac Electrophysiology, Ross Heart Hospital at the Ohio State University Medical Center in Columbus, who performed the first U.S. procedure. "The open-irrigated catheter performed well with excellent maneuverability, torque and catheter stability."
The Blazer Open-Irrigated Catheter integrates Total Tip Cooling Technology with the high-performance Blazer® Catheter Platform. Total Tip Cooling Technology is intended to offer consistent cooling of the entire ablation tip electrode throughout radiofrequency energy delivery.
"The first U.S. use of the Blazer Open-Irrigated Catheter highlights our continued focus on providing the most advanced ablation technologies to electrophysiologists," said Hank Kucheman, Executive Vice President and President of Boston Scientific's Cardiology, Rhythm, and Vascular Group.
In the U.S., the Blazer Open-Irrigated Catheter is an investigational device and is limited by applicable law to investigational use only and is not available for sale.
Ablation may offer better outcomes than medication for ventricular tachycardia