This article is more than 5 years old. Information may no longer be current.
FDA approves open-irrigated catheter for patients with type I atrial flutter
Click Here to Manage Email Alerts
Boston Scientific announced it has received FDA approval for the company’s first open-irrigated radiofrequency ablation catheter to be available in the United States for the treatment of type I atrial flutter.
The Blazer open-irrigated catheter features Total Tip Cooling technology, which cools the tip of the catheter throughout the ablation procedure, enabling more accurate lesion creation, the release said.
Approval was based on the results of BLOCk-CTI, a prospective, randomized trial of 302 patients that investigated the safety and efficacy of the catheter in this patient population.
“Successful results from the BLOCk-CTI trial demonstrate that the Blazer open-irrigated catheter is safe and effective for the ablation of atrial flutter,” Tom McElderry, MD, principal investigator, associate professor and section chief of electrophysiology at the University of Alabama at Birmingham, said in the release.
“This newly approved ablation tool was built on the proven Blazer platform of therapeutic catheters and facilitates excellent maneuverability, consistent cooling and stability during procedures,” he said.
Boston Scientific’s IntellaTip MiFi open-irrigated catheter, which is designed for all cardiac ablation procedures, also has the same cooling technology. This catheter received CE mark approval in January, but it is still considered an investigational device in the United States.
Disclosure: McElderry reports financial ties with Boston Scientific.