Stereotaxis Inc. announced that it has completed the clinical trial required for FDA clearance of the company's Vdrive(TM) Robotic Navigation System with V-Loop(TM) 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 first quarter of 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(TM) 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. The Vdrive with V-Loop system, already part of the clinical routine of several European electrophysiology (EP) labs, is indicated for remotely controlling the advancement, retraction, rotation, tip deflection, and loop size of a compatible catheter.

For Niobe(R) ES remote navigation procedures, the Vdrive with V-Loop system can improve efficiency and accuracy of loop catheter management. In the U.S., an estimated 60,000 loop catheters are used each year in complex EP procedures.