OD-OS retinal device receives clearances

December 2, 2009

OD-OS has received FDA 510(k) clearance and CE mark approval for its recently released navigated retina laser therapy system (Navilas).

Grapevine, TX, and Teltow, Germany

-OD-OS has received FDA 510(k) clearance and CE mark approval for its recently released navigated retina laser therapy system (Navilas).

According to the company, the system incorporates in one device advanced imaging with retinal laser therapy in a planned and controlled way using image registration. Integrated workflow is designed to support the safety, accuracy, speed, comfort, and transparency of retina laser photocoagulation. In an effort to be ergonomic, the system also provides physicians with freedom-of-neck movement and the ability to adjust their height and proximity to the patient.

The system produces a live image of the fundus in true color, as well as fluorescein angiography with 50° 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, according to the company.

“In trials, initial accuracy results with [the device] indicate a microaneurysm hit rate of 92% as evidenced by post-treatment color overlay photographs,” reported William Freeman, MD, professor and director of the Jacobs Retina Center at the Shiley Eye Center, University of California, San Diego, during a retina subspecialty day presentation at the recent American Academy of Ophthalmology annual meeting in San Francisco, according to a press release from the company.

The device debuted in the United States in September in New York at the Retina Congress and made its first appearance in Germany in September in Frankfurt at the Vitreo-Retinal Symposium.