Stereotaxis Announces European Adoption Milestone and Health Canada Market Clearance for Vdrive™ System
ST. LOUIS, Feb. 8, 2012 -- Stereotaxis, Inc. announced that its Vdrive™ Robotic Navigation System, which provides physicians the ability to remotely manipulate traditionally non-robotic catheters, is expected to surpass 500 clinical procedures in Europe in February. The company also announced it has received regulatory clearance from Health Canada to commercially market the device in Canada.
Since the initial product release in Europe in 2011, the Vdrive system has been installed in nine centers, with units scheduled to be installed in additional centers during the first quarter of 2012. The initial nine centers have performed 473 clinical cases with approximately 80% being completed in the left atrium of the heart.
In a fully remote procedure environment, the Vdrive system increases the clinical techniques available to the physician and reduces the need to re-enter the sterile field to adjust devices. Initial clinical data from European physicians demonstrates that this simplification saves 30 minutes(1) or more in robotic procedures, depending on the individual clinical technique. Furthermore, the addition of robotic diagnostic catheter manipulation is another step in Stereotaxis' vision to improve device control. Stereotaxis' broad Epoch™ solutions portfolio also includes precise magnetic control of ablation catheters with Niobe® ES and integrated display and control of multiple lab technologies with the Odyssey™ Clinical Information Management System.
The design of the Vdrive system allows the robotic hardware to adapt to different clinical techniques depending on the disposable adaptor that is attached to the arm:
V-Loop™ circular catheter manipulator allows control of circular diagnostic catheters, primarily in left atrial procedures.
V-CAS™ catheter advancement system allows advancement and retraction of the magnetic catheter as well as robotic manipulation of catheter introducer sheaths that are already in use during the procedure.
V-CAS Deflect™ catheter advancement system is a more advanced device that includes an integrated robotic deflectable sheath.
Initial positive results from multiple physician users confirmed the significant clinical value delivered by the Vdrive system related to procedure efficiency.
Dr. Georg Noelker of the Herz- und Diabeteszentrum NRW in Bad Oeynhausen, Germany commented on the V-Loop system: "We have adopted Vdrive for navigating the circular mapping catheter for all of our left atrial procedures. Our initial experience with Vdrive has shown that we can reduce our left atrial procedures times by approximately 30%, and can further reduce our fluoroscopy times by an additional 14% over our previous times with magnetic navigation alone."
Dr. Xu Chen of the Rigshospitalet in Copenhagen commented on the V-CAS system: "The addition of robotic sheath control to a magnetic procedure allows me to efficiently access even challenging areas of the heart chambers and focus on patient therapy instead of catheter control. The Vdrive control was intuitive and did not take long to implement as a part of my procedure. In difficult cases, the Vdrive control even reduced my total procedure time."
Dr. Petr Neuzil of Homolce Hospital in Prague shared his perspective on the V-CAS Deflect system: "The advancements in the Vdrive technology use the best of previous magnetic and robotic systems to provide a new level of catheter control, which is expected to improve outcomes in ablation procedures."
The regulatory milestone in Canada covers both the V-Loop circular catheter manipulator and the V-CAS catheter advancement system with sheath manipulator. The Company's 510(k) submission for the V-Loop circular catheter manipulator is under review by the U.S. Food and Drug Administration.
(1) Stereotaxis data on file