The FDA approved the Blazer open-irrigated (OI) radiofrequency ablation catheter (Boston Scientific) on March 10 to treat patients with type 1 atrial flutter.
The approval was based on results of a prospective, randomized trial that evaluated the catheter in 302 patients at 24 U.S. sites who had sustained or recurrent type 1 atrial flutter.
The Blazer OI catheter is used in ablation procedures to restore normal heart rhythm. The catheter has a technology that cools the catheter tip consistently during the ablation procedure, according to a Boston Scientific news release.
The company also has an investigational IntellaTip MiFi OI catheter intended for use in cardiac ablation procedures that has the same cooling technology. That catheter is not yet FDA-approved, but it is commercially available in Europe.