Stereotaxis, Inc. announced today that it has received 510(k) clearance by the Food and Drug Administration (FDA) for its Vdrive® with V-CAS™ Catheter Advancement System in the U.S., representing the Company's third Vdrive system product to be cleared for market entry.
The Company also announced that it has received regulatory approval of its Odyssey® product line by the Japan Pharmaceuticals and Medical Devices Agency, the country's equivalent to the U.S. FDA.
Stereotaxis' Vdrive with V-Loop™ Variable Loop Catheter Manipulator received U.S. clearance in September 2014 and its Vdrive with V-Sono™ Intracardiac Echocardiography Catheter Manipulator has been available since 2013.
"The Vdrive system and disposable suite provides flexibility in robotic catheter and sheath control, adaptable to a physician's individual workflow and product preferences," said William C. Mills, Stereotaxis Chief Executive Officer. "As additional Vdrive system accessories gain market approval in the U.S., we move closer to our vision of a fully remote electrophysiology procedure environment."
The Vdrive with V-CAS system, which was first released in Europe in 2011, 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 stability and support to the ablation catheter during therapy delivery.
Bruno Schwagten, M.D., Ph.D. at ZNA Middelheim Hospital in Belgium, who has performed Stereotaxis magnetic navigation procedures since 2008 and started using the Vdrive with V-CAS system in 2012, said, "The addition of robotic sheath control to a magnetic procedure has simplified the therapy process and enhanced patient safety, allowing me to efficiently access even the most challenging areas of the heart chambers."
In Japan, approval of the Stereotaxis Odyssey Vision™ system for use in conjunction with the Niobe® ES remote magnetic navigation system comes three months after the Company's first commercial order in that country. The Odyssey Vision system, together with the Odyssey Cinema™ solutions, provides a consolidated user interface of all lab information during a Niobe procedure, as well as real-time or recorded viewing of procedures across networks and institutions. The Company expects to submit its Vdrive system for regulatory review in Japan during the first quarter of 2015.