Stereotaxis Gets FDA Green Light for Catheter-Guiding Product

St. Louis, Mo.-based Stereotaxis said Monday that the FDA has cleared its Vdrive with V-CAS catheter advancement system for marketing in the U.S. The system lets doctors remotely control the movement of a compatible fixed-curve transseptal sheath and catheter.

This is the third product in the company’s Vdrive portfolio to receive 510(k) clearance. The FDA OK’d the Vdrive with V-Loop variable loop catheter manipulator in September and the Vdrive with V-Sono intracardiac echocardiography catheter manipulator in 2013.

CEO William Mills said the recent V drive authorizations further Stereotaxis’ vision of a “fully remote electrophysiology procedure environment.”

The Vdrive with V-CAS has been available in Europe since 2011.

Separately, Stereotaxis said that over 75,000 procedures have been completed using its Epoch Solution magnetic navigation technology. The fully remote electrophysiology platform — comprised of the Niobe ES navigation system, Vdrive systems and Odyssey solutions — was first commercialized in 2003. — Kellen Owings