Stereotaxis Gets FDA Clearance To Market Vdrive With V-Loop System

(RTTNews) - Stereotaxis, Inc. (STXS), a healthcare technology and innovation company, announced Thursday that it has received 510(k) clearance by the Food and Drug Administration to market its Vdrive Robotic Navigation System with V-Loop Variable Loop Catheter Manipulator in the U.S.

The company submitted a 510(k) Premarket Notification for the Vdrive with V-Loop system in March, following completion of a 120-patient, multi-center clinical study.

The company noted that the Vdrive with V-Loop system is its second Vdrive product to receive FDA clearance for use in the U.S. 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 U.S.," said

William Mills, Stereotaxis Chief Executive Officer, said, "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 (EP) 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.

With the launch of this new product in the U.S., the Vdrive Duo Robotic Navigation system can eliminate manual manipulation of the two most commonly repositioned diagnostic tools utilized during ablation procedures (variable loop and ICE catheters), enabling single user workflow and greater catheter stability.