Image-guided interventional surgery firm Stereotaxis has received the European CE Mark for its Vdrive robotic navigation system.
In addition, the St. Louis-based firm reported that Tamas Szili-Torok, MD, PhD, of Erasmus Medical Center in the Netherlands, successfully used Vdrive to treat atrial fibrillation in a patient with known difficult heart anatomy. In the first human case for Vdrive, Szili-Torok completed the entire case without having to manually adjust the circular mapping catheter, Stereotaxis said.
Stereotaxis' 510(k) application is still under review by the U.S. Food and Drug Administration (FDA).
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