Stereotaxis Announces Completion of Clinical Trial of Vdrive with V-Loop System

Stereotaxis

announced today that it has completed the clinical trial required for FDA clearance of the Company's Vdrive Robotic Navigation System with V-Loop Circular Catheter Manipulator. Results of the 120-patient study, which was conducted at three Stereotaxis sites in the U.S. and two in Europe, will be included in a 510(k) Premarket Notification the Company intends to submit in the Q1 2014. If cleared by the FDA, the Vdrive with V-Loop system will be the Company's second Vdrive product to be cleared for use in the U.S. Its Vdrive with V-Sono Intracardiac Echocardiography Catheter Manipulator received FDA clearance in July 2013 and has been utilized in more than 50 cardiac ablation procedures to date in the U.S.