Navilas® Laser System 577+ Receives U.S. FDA Clearance
OD-OS, the world leader in Navigated Retinal Imaging and Laser Treatment, today announced the company has received FDA 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new Navilas 577+ ophthalmic laser system.
Navilas 577+ features a navigated, yellow 577 nm treatment laser and the option to perform tissue-friendly navigated microsecond-pulsed treatments.
“We are pleased to introduce our latest innovation to Retina Specialists in the U.S. – a community that was quick to realize the potential of a more precise, faster stabilizing retinal laser which adds significant durability to visual gains from Anti-VEGF injection treatment. With the optimal absorption profile of the yellow 577 nm laser wavelength we strive to further extend the proven precision of Navilas into target specific level of retinal tissue”, stated Dr. Winfried Teiwes, OD-OS CEO. He added, “We’re seeing an increasing interest in tissue-friendly, microsecond-pulsed laser applications. With Navilas a large number of invisible low intensity laser effects can be applied rapidly and precisely to the retina without undesired gaps or overlap – making this therapy significantly more practicable. Furthermore, we consider the unique digital documentation of otherwise invisible laser effects to be essential in standardizing therapy and achieving more consistent outcomes.”
The Navilas® Laser System 577+ is a retinal photocoagulator integrated with a digital fundus camera. It is indicated for use in
• Retinal Photocoagulation for the treatment of Clinically Significant Diabetic Macular Edema (Focal or Grid Laser), Proliferative Diabetic Retinopathy (Panretinal Photocoagulation), Sub-retinal (Choroidal) Neovascularization (Focal Laser), Central and Branch Retinal Vein Occlusion (Scatter Laser Photocoagulation, Focal or Grid Laser), Lattice Degeneration, Retinal Tears and Detachments (Laser Retinopexy).
• imaging (capture, display, storage and manipulation) of the retina of the eye, including color, fluorescein angiography and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.
About OD-OS: OD-OS GmbH is located in Teltow, Germany and Irvine, California, USA and has commercialized the Navilas Navigated Laser in the US, Canada, Europe, Korea, India, and Japan. More approvals for Navilas in China and Mexico are anticipated in the next months.
For further information, please contact:
Mr. Dennis Dowell
+ (949) 415 7258