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ST. LOUIS, Jan. 7, 2014 (GLOBE NEWSWIRE) -- 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
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.
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
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.
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. With over 100 patents for use in a hospital's interventional surgical suite, Stereotaxis helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced collaboration of life-saving information. Stereotaxis' core Epoch™ Solution includes the Niobe® ES Remote Magnetic Navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management systems and the Vdrive™ Robotic Mechanical Navigation system and consumables.