ST. LOUIS — Stereotaxis, Inc. (Nasdaq:STXS) announced today 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 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 Vdrive with V-Loop system is the Company’s 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 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 (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, which is used in approximately 60,000 complex EP procedures worldwide each year. 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.
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch Solution includes the Niobe ES Remote Magnetic Navigation system, the Odyssey portfolio of lab optimization, networking and patient information management systems and the Vdrive Robotic Navigation system and consumables.
The core components of Stereotaxis systems have received regulatory clearance in the U.S., European Union, Canada, China, Japan and elsewhere. The V-Sono ICE catheter manipulator and V-Loop variable loop catheter manipulator have received U.S. clearance, and the V-CAS catheter advancement system has been submitted for review by the U.S. Food and Drug Administration. For more information, please visit www.stereotaxis.com.
Press release via Stereotaxis.