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Stereotaxis Closes Clinical Trial Of Vdrive With V-Loop System - Quick Facts
(RTTNews.com) - Stereotaxis Inc. (STXS) announced Tuesday 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.
According to the company, 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 company noted that the Vdrive with V-Loop system, already part of the clinical routine of several European electrophysiology or EP labs, is indicated for remotely controlling the advancement, retraction, rotation, tip deflection, and loop size of a compatible catheter.
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