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|Stereotaxis Submits 510(k) Application to FDA for Vdrive(TM) with V-Loop(TM) System|
In addition, the company announced today that
"Adding this technology to our minimally invasive arrhythmia lab, which is already cutting-edge with its use of robotic imaging-guided technology, is further enhancing the precision and safety of heart procedures," says Dr.
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. In conjunction with the Company's Niobe® ES magnetic navigation system, the Vdrive with V-Loop system can improve efficiency and accuracy of loop catheter management during EP procedures. In the U.S., an estimated 60,000 loop catheters are used each year in complex EP procedures.
The core components of
This press release includes statements that may constitute "forward-looking" statements, usually containing the words "believe," "estimate," "project," "expect" or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company's ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company's products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, the outcome of various shareholder litigation filed against
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