Stereotaxis has announced 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.
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 USA. Its Vdrive with V-Sono Intracardiac Echocardiography Catheter Manipulator received FDA clearance in July 2013 and has been utilized, according to the company, in more than 50 cardiac ablation procedures to date in the USA.
The Vdrive with V-Loop system, already part of the clinical routine of several European electrophysiology 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.