Medical devices manufacturer Boston Scientific has secured approval from the US Food and Drug Administration (FDA) for its Blazer open-irrigated (OI) radiofrequency ablation catheter.
The Blazer catheter is approved to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart.
The company developed the Blazer OI catheter for use in ablation procedures to restore a normal heart rhythm for patients in atrial flutter.
During the procedure, localized electrical energy is provided via an electrode on the tip of a catheter into the heart muscle, producing heat to destroy a small area of the tissue whih leads to the abnormal heart rhythm.
Total Tip cooling technology of the Blazer OI catheter enables to cool the catheter tip consistently during the ablation procedure.
The approval was based on data from the BLOCk-CTI randomized clinical trial, which assessed the safety and effectiveness of the Blazer OI catheter in patients with sustained or recurrent Type 1 atrial flutter.
In the trial, Boston Scientific recruited 302 patients at 24 sites in the US.
Boston Scientific cardiac rhythm management chief medical officer Dr Kenneth Stein said: "The Blazer and IntellaTip MiFi open-irrigated catheters provide electrophysiologists with technology that leverages our established platforms to help improve the health of patients around the world."
In January, the company also obtained CE mark approval for its IntellaTip MiFi OI catheter for use in all cardiac ablation procedures.
The IntellaTip MiFi OI catheter provides precise and multidimensional information through mini-electrodes to the physicians. It is an investigational device and not available for sale in the US.