FDA clears Viking Systems' Next Generation 3DHD visualization system

Sep 8 2010

Viking Systems, Inc. (OTCBB:VKNG) announced today that it has received clearance of its 510(k) application by the Food and Drug Administration related to its Next Generation 3DHD visualization system. The System is scheduled for market launch in Washington D.C. at this year's American College of Surgeons' Annual Clinical Congress which will be held from October 3-7.    

Jed Kennedy, Viking President & CEO said, "We are very pleased to have received timely FDA 510(k) clearance of our Next Gen system for a broad base of minimally invasive procedures including general surgery, urology, gynecology, spinal, bariatric, ENT and thoracic."  Kennedy went on to say, "With the 510(k) in place, we will now focus on completing the documentation required to apply the CE mark to the 3DHD system." The CE mark demonstrates compliance with the European community's Medical Device Directive.

Kennedy continued, "Because Viking is ISO13485-certified, we will be able to self-certify the 3DHD for the European community. This keeps us on track to be in the U.S. and European markets in the fourth quarter of 2010 as planned."

Nearly all minimally invasive procedures are currently performed with a 2D camera. The Company plans to provide surgeons with high quality 3D vision in a cost effective and flexible format which has the potential to not only improve the quality of care but also to reduce procedure time and therefore cost of procedures.

Viking's Next Generation 3DHD system provides surgeons from a broad base of surgical specialties with the ability to perform complex minimally invasive surgery with a revolutionary vision system that restores their natural depth perception previously sacrificed with 2D systems. Viking Systems' 3DHD system is planned to offer surgeons the choice of two different proprietary 3D optical systems. The Company also plans to offer a 2DHD camera for use with the system for surgeons that may prefer this modality for less complex cases. Jed Kennedy elaborated, "The 3DHD system will offer hospital administrators a flexible solution, intended to provide a vision system solution for the visualization needs of minimally invasive surgeons."

In October 2009, at the American College of Surgeons' Annual Clinical Congress in Chicago, Viking Systems first publicly demonstrated the Next Generation 3DHD camera system utilizing a prototype Sony 3DHD flat panel display. Since this initial demonstration, Viking Systems and Sony have collaborated on presentations at a series of Surgical Congresses and meetings to expose surgical thought leaders in targeted specialties to the 3DHD system prior to its official launch in October 2010.

Most recently, cardiothoracic surgeons attending the 5th International Symposium on Hybrid Approach to Congenital Heart Disease in Columbus, Ohio, had the opportunity to gain some hands on experience with the 3DHD system. Jed Kennedy reported, "Once again, surgeons were 'blown away' by the quality of the image the Viking 3DHD vision system provides and with its natural depth perception. Obviously, when performing minimally invasive thoracic surgery the surgeons want all the help they can get. We believe 3D visualization will significantly help to accelerate the conversion of open thoracic surgery procedures to a minimally invasive approach."

Viking Systems intends to begin production of this unique Next Generation system and currently plans to begin deliveries of systems for the U.S. and European markets in the fourth quarter of 2010. Viking Systems believes that at launch its high quality 3DHD visualization system will be the only cost effective, standalone 3DHD solution available for minimally invasive surgery.