Stereotaxis, Inc. announced today that it has submitted a 510(k) Premarket Notification to the Food and Drug Administration (FDA) for the Company's Vdrive™ Robotic Navigation System with V-CAS™ Catheter Advancement System.
The submission, which follows the Company's 510(k) application for Vdrive with V-Loop™ Variable Loop Catheter Manipulator on March 31, includes both the single-arm system (Vdrive) and the two-arm system (Vdrive Duo).
The Vdrive with V-CAS system is currently available in the European Union and Canada and has been used in more than 1,100 procedures since its introduction in 2011. The system allows physicians to remotely control the advancement, retraction and rotation of a compatible fixed curve transseptal sheath, in conjunction with a magnetic ablation catheter. Utilized in the majority of ablation procedures, the fixed curve transseptal sheath provides greater stability and support to the ablation catheter during therapy delivery.
"We are excited about the prospect of bringing the Vdrive with V-CAS system to the U.S. market, where we believe it could have significant potential for streamlining physician workflow," said William C. Mills, Stereotaxis Chief Executive Officer. "With the addition of this system, physicians have reported improved maneuverability as well as efficient use of devices during remote magnetic procedures."
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced collaboration of life-saving information. Stereotaxis' core Epoch™ Solution includes the Niobe® ES Remote Magnetic Navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management systems and the Vdrive™ Robotic Navigation system and consumables.
The core components of Stereotaxis systems have received regulatory clearance in the U.S., European Union, Canada, China, Japan and elsewhere. The V-Sono™ ICE catheter manipulator has received U.S. clearance, and the V-Loop™ variable loop catheter manipulator and V-CAS catheter advancement system have been submitted for review by the U.S. Food and Drug Administration.