The Vdrive with V-Loop technology allows physicians to remotely manipulate a compatible mapping catheter, a device commonly used in the electrophysiology lab. The V-Loop system is compatible with both variable loop and ICE catheters, which are among the most repositioned diagnostic tools during ablation procedures, Stereotaxis said.
The V-Loop system joins V-Sono, another Vdrive product which won FDA clearance last year. Stereotaxis’ V-CAS and V-CAS Deflect catheter advancement systems are not yet cleared for the U.S.
Stereotaxis has had a few rough years, but is making progress after escaping a pair of shareholder lawsuits without penalty this year.
The 1st lawsuit, filed in October 2011, sued the company as well as CEO Michael Kaminski and former CFO Daniel Johnston for allegedly misleading investors about its market position. A derivative lawsuit filed in December 2011 also accused the board of directors and certain company officers of concealing important information to hide the company’s struggles.
Stereotaxis took a major Wall Street hit in August 2011 after suspending its full-year guidance on a particularly weak 2nd quarter, after which then-CFO Johnston resigned. The shareholder lawsuits claimed that Stereotaxis and its leadership had covered up softness company’s flagship Niobe catheter navigation systems, leading to the sudden stock collapse and exposing the company to federal securities violations.