Boston Scientific’s Open-Irrigated Catheter Snags FDA Approval

Boston Scientific has received FDA approval for its Blazer open-irrigated radiofrequency ablation catheter.

The device is intended for use in ablation procedures to reestablish a normal heart rhythm for patients in atrial flutter.

The approval was based on data from a randomized trial that assessed the safety in efficacy in patients with sustained or recurrent Type 1 atrial flutter, the company says.

This is the first time the company will commercialize an open-irrigated catheter in U.S. markets. — Anisa Jibrell