Stereotaxis has announced it has received regulatory clearance from Health Canada to market its Vdrive robotic navigation system in Canada. The system allows physicians to remotely manipulate traditionally non-robotic catheters. The company also has announced that the use of the device is expected to surpass 500 clinical procedures in Europe in February.
Since the initial product release in Europe in 2011, the Vdrive system has been installed in nine centres where 473 clinical cases have been performed, with approximately 80% being completed in the left atrium of the heart. The company announced that some other units have been scheduled to be installed in additional centres during the first quarter of 2012.
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 or more in robotic procedures, depending on the individual clinical technique.
“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,” said Georg Noelker, Herz- und Diabeteszentrum NRW, Bad Oeynhausen, Germany.
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.
Xu Chen, Rigshospitalet, Copenhagen, Denmark, 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.”
The regulatory approval 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 US Food and Drug Administration (FDA).