Compact Navilas® Laser System 577s Receives U.S. FDA Clearance
Introduction of a compact Navilas Laser System to bring the benefits of navigated retina laser into day-to-day clinical routine
OD-OS, the global leader in the development and commercialization of navigated laser photocoagulators for Ophthalmology, today announced the FDA 510(k) clearance and immediate U.S. commercial availability of the Navilas® 577s, the most compact all-digital system for navigated focal and peripheral laser treatments.
“We are thrilled to announce FDA clearance of Navilas 577s, the newest companion to our flagship navigated laser, Navilas® 577+. Navilas 577s retains the proven benefits of all-digital navigated laser photocoagulation, offering a more precise and complete treatment in a compact and affordable package” said Dr. Winfried Teiwes, founder and chief executive officer at OD-OS. “With Navilas 577s we focused on creating the most user-friendly laser to date, bringing the power of navigation to practices and clinics of all sizes.”
David Brown, MD (Retina Consultants of Houston, TX) was the first U.S. physician to treat patients with the new Navilas 577s before FDA clearance during his visit to Berlin, Germany, "I am very impressed with the new Navilas 577s PRP. It feels ergonomic and straightforward - the system literally lets me paint the peripheral retina with uniform spots in a very short amount of time. It was very well tolerated by the patients, with only topical anesthesia. Navilas now has an industry leading PRP tool to omplement its unrivalled and already well-known focal laser capability."
Navilas 577s enables physicians to digitally pre-plan the entire laser therapy on fundus images as well as external diagnostic images and precisely execute this therapy plan under computer guidance. Unlike any other retina laser, Navilas offers focal treatments without a contact lens and infrared illumination for unsurpassed patient comfort. A large field of view and assisted pattern positioning greatly improve speed in panretinal and focal treatments.
Indications for use: Navilas® Laser System 577s and the Navilas Laser System 577+ are retinal photocoagulators integrated with a digital fundus camera. They are 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 and infrared imaging; and for aiding in the diagnosis and treatment of ocular pathology in the posterior segment of the eye.
OD-OS is the first and only company to develop and commercialize Navigated Laser treatments in Ophthalmology.
About OD-OS: OD-OS, Inc., a privately-held medical device company founded in 2008 with offices in Irvine, Calif. and Teltow, Germany, is dedicated to the development and commercialization of advanced navigated imaging and laser treatment technology used to facilitate the advanced treatment of retinal eye diseases, many of which may lead to permanent blindness. Visit www.od-os.com for more details.
For further information, please contact:
Dennis Dowell MFA., MS.,
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OD-OS Inc. | 6201 Oak Canyon Drive, Suite 200 | Irvine, CA 92618
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