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Stereotaxis submits 510(k) application to FDA for Vdrive with V-Loop system

Stereotaxis has submitted a 510(k) Premarket Notification with the Food and Drug Administration (FDA) for the Company's Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator.

This submission includes both the single arm system (Vdrive) and the two arm system (Vdrive Duo). 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 75 cardiac ablation procedures to date in North America.

In addition, the company announced today that Sunnybrook Health Sciences Centre in Toronto, Canada has installed its Vdrive Duo System, representing the first installation of the Duo System in North America.

An expansion of the Vdrive family of products, the Vdrive Duo System includes a second robotic arm offering remote control and manipulation of two compatible devices at the same time.

Sunnybrook’s Schulich Heart Centre cardiologist and director of Arrhythmia Services Dr Eugene Crystal said adding this technology to center’s 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.

"We can now access really challenging areas of the heart chambers, which results in greater accuracy during ablation and a reduced risk of complications for patients," Dr Crystal added.

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 US, an estimated 60,000 loop catheters are used each year in complex EP procedures.