FDA approves catheter to treat patients in type 1 atrial flutter
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.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.