Stereotaxis has announced that it has received 510(k) clearance by the Food and Drug Administration (FDA) to market its Vdrive robotic navigation system with V-Loop variable loop catheter manipulator in the USA. The company submitted a 510(k) Premarket Notification for the Vdrive with V–Loop system in March, following completion of a 120-patient, multicentre clinical study.
The Vdrive with V–Loop system is the company’s second Vdrive product to receive FDA clearance for use in the USA. In July 2013, Stereotaxis was granted FDA clearance of its Vdrive with V-Sono ICE catheter manipulator. This past June, the company submitted a 510(k) application to the FDA for its Vdrive with V-CAS catheter advancement system.
“This is another key step in our efforts to bring our full suite of Vdrive products to market in the USA,” says William C Mills, Stereotaxis chief executive officer. “Our work to continually evolve the Vdrive platform and expand its availability reflects our commitment to achieving greater safety, operator efficiencies and patient outcomes in the electrophysiology lab through advanced robotic technologies.”
Employed in conjunction with the company’s Niobe ES magnetic navigation system, the Vdrive with V–Loop system is designed to remotely control the advancement, retraction, rotation, tip deflection and loop size of a compatible circular mapping catheter, which is used in approximately 60,000 complex electrophysiology procedures worldwide each year. With the launch of this new product in the USA, the Vdrive Duo robotic navigation system can eliminate manual manipulation of the two most commonly repositioned diagnostic tools utilised during ablation procedures (variable loop and ICE catheters), enabling single user workflow and greater catheter stability.