(Dallas, Texas, Nov 2, 2009) OD-OS announces that it has earned FDA 510 k clearance to market NAVILAS its product for retinal laser therapy NAVILAS, allows physicians to move beyond conventional slit lamp based photocoagulation that provides only a partial slit image of the retina. The NAVILAS system produces a live image of the fundus in true color, IR and red-free as well as fluorescein angiography (FA) with 50 degree field of view on a monitor panable across the fundus. In contrast to fundus cameras or scanning laser ophthalmoscopes, this patented imaging technology is capable of real time imaging of the retina in color both mydriatic and non-mydriatic – while including a treatment laser to treat the retina. “In trials, initial accuracy results with NAVILAS indicate a microaneurysm hit rate of 92% as evidenced by post treatment color overlay photographs,” reported William Freeman, M.D.., Professor and Director of the Jacobs retina Center at the UCSD Shiley eye Center, La Jolla, CA, during his presentation at retina Subspecialty Day 2009 of the AAO in San Francisco… With NAVILAS, doctors have freedom of neck movement and are able to adjust their height and proximity to the patient for maximum ergonomic benefits. “The neck and back will strain of slit lamp examination be greatly reduced,” said Dr.
Michael Ober, retina consultants of Michigan, Southfield Michigan. NAVILAS made its first appearances in the US in New York in September at the retina Congress and last week at the American Academy of ophthalmology in San Francisco. “In both venues, doctors were excited by the new technology that will, for the first time, allow them to use what we call retina navigation, the ability to IMAGE PLAN TREAT and DOCUMENT retina disorders,” said Winfried Teiwes, CEO. For more information on the NAVILAS system, call (877) 628-6367 or visit. About OD OS OD-OS is ISO 9001 and ISO 13485 certified medical device company headquartered in Teltow/Berlin, Germany. Its US operation, responsible for marketing, sales and support, is located Grapevine/Dallas, Texas.
OD-OS is a subsidiary of SensoMotoric instruments (SMI), the technology leader in eye tracking and registration solutions for refractive laser surgery. Over the past 15 years, SMI has supplied technology to most major refractive laser manufacturers.