Additional Relevant Details FDA approval granted on the heels of CE Mark for the IntellaTip MiFi open-irrigated catheter

The Blazer OI catheter was granted approval based on data from the BLOCk-CTI clinical trial, a prospective, randomized trial that enrolled 302 patients at 24 sites in the U.S. and evaluated the safety and effectiveness of the Blazer OI catheter in patients with sustained or recurrent Type 1 atrial flutter.

In January, the company also received CE Mark for the IntellaTip MiFi open-irrigated (OI) catheter for use in all cardiac ablation procedures. The IntellaTip MiFi OI catheter is designed to provide physicians precise, multidimensional information via mini-electrodes which deliver a highly localized signal reflecting exactly what is happening at the tip of the catheter in real-time during the ablation procedure. The IntellaTip MiFi OI catheter also features the same Total Tip Cooling technology as the Blazer OI catheter.