January 27, 2011 – The first U.S.-procedure to use a new open-irrigated catheter was completed as part of the BLOCk-CTI trial. The study is using Boston Scientific’s Blazer Open-Irrigated Catheter to evaluate its safety and effectiveness in patients with sustained or recurrent type 1 atrial flutter.
BLOCk-CTI is a prospective, randomized trial that will enroll up to 240 patients at 22 sites in the United States.
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. Daoud performed the first U.S. procedure. "The open-irrigated catheter performed well with excellent maneuverability, torque and catheter stability."
The device 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.
It is currently an investigational device in the United States and is not available for sale.
For more information: www.bostonscientific.com