Boston Scientific (BSX +0.3%) says it's gotten FDA approval for its Blazer Open-Irrigated catheter, a radiofrequency ablation device, marking the first time that the company will offer an OI catheter in the U.S.
The agency gave the catheter approval to treat Type I atrial flutter; it's designed to restore normal heart rhythm for patients during ablation procedures, using localizd electrical energy.
The move comes after successful results from Boston Scientific's BLOCk-CTI clinical trial, covering 302 patients at 24 sites.
Earlier, BSX was down 0.4% after hours.
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