Home » Boston Scientific’s Open-Irrigated Catheter Snags FDA Approval
Boston Scientific’s Open-Irrigated Catheter Snags FDA Approval
March 11, 2016
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
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