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Stereotaxis Completes Clinical Trial of Vdrive(TM) With V-Loop(TM) System







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Stereotaxis, Inc. (MM) (NASDAQ:STXS)
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Today : Tuesday 7 January 2014
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Stereotaxis, Inc. (Nasdaq:STXS) 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 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™ 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® 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.