![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Boston Scientific’s Open-Irrigated Catheter Snags FDA Approval
Boston Scientific’s Open-Irrigated Catheter Snags FDA Approval
![Boston Scientific Logo](https://www.fdanews.com/ext/resources/test/Device_Images3/Boston-Scientific.gif?t=1576639660&width=430)
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
Upcoming Events
-
11Jul
-
18Jul
-
21Oct