CE Mark and first human case for Vdrive robotic navigation system


Stereotaxis announced on 11 January 2011 the first successful cardiac ablation procedure with the Vdrive robotic navigation system as the company received CE Mark for this latest innovation.

In the first procedure with the Vdrive system, Tamas Szili-Torok from the department of Clinical Electrophysiology at the Erasmus Medical Center in The Netherlands, successfully treated atrial fibrillation in a patient with known difficult heart anatomy. Szili-Torok was able to complete the entire case without having to manually adjust the circular mapping catheter. “This first use of the Vdrive robotic navigation system exceeded my expectations,” said Szili-Torok.

Stereotaxis’ Vdrive system is a robotic navigation technology that compliments the Stereotaxis remote magnetic navigation system. Designed to manipulate accessory devices such as variable loop catheters, steerable sheaths, and ultrasound catheters, Vdrive combines magnetic navigation with the Odyssey information management system to bring precise control during catheter-based electrophysiology procedures.

“The Vdrive system is an extension of the magnetic navigation platform capabilities,” said Michael P. Kaminski, president and chief executive officer of Stereotaxis, “Along with QuickCAS (Catheter Advancement System), the Vdrive system represents an additional component to our expanding disposable product portfolio designed to bring compelling efficiency to the Electrophysiology lab.”

The Vdrive system is commercially available in the European Union. The Vdrive system is not currently available for purchase in the USA as it is still under 510(k) review by the FDA.