Stereotaxis has announced that it has submitted a 510(k) premarket notification to the US 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 31 March, 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 company states. 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. Utilised in the majority of ablation procedures, according to a company release, 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 US market, where we believe it could have significant potential for streamlining physician workflow,” says 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.”