Lumenis Ltd announced the Novus Varia multi-color photocoagulation laser system received marketing clearance from the U.S. Food & Drug Administration for the treatment of a wide range of retinal diseases. The world's first solid-state multi-wavelength ophthalmic laser to operate on any standard electrical outlet, Novus Varia requires none of the regular maintenance or special cooling of other multi-color photocoagulation lasers.
The Novus Varia photocoagulator is the first diode laser to offer the spectrum of green, yellow and red light in one standard platform. The ability to instantly switch wavelengths and change power settings on a color touch screen provides greater flexibility during treatment, which is particularly beneficial in penetrating mild vitreous opacity, sclerotic lens, or mild vitreous hemorrhage. The Novus Varia photocoagulator is a diode-pumped semi-conductor based platform, which unlike krypton or argon dye based multi-color photocoagulators, does not require external hookups for operation, frequent maintenance or special cooling.
Age-related macular degeneration (AMD), diabetic retinopathy, diabetic macular edema, retinopathy of prematurity and retinal vein occlusions are among the retinal conditions covered in the FDA clearance.
"The Novus Varia photocoagulator is an important advancement to today's ophthalmic laser products since it has the unique ability to produce three distinct and separate wavelengths ? green, yellow and red ? from a single, solid-state laser platform," said Carmen Puliafito, Chairman of the Department of Ophthalmology and Medical Director at Anne Bates Leach Eye Hospital in Miami, Florida.
"Novus Varia integrates the best of today's photocoagulation technology into a highly-adaptable, energy-efficient laser system," said Robert Grant, Executive Vice President of Lumenis. "The transfer of Lumenis ophthalmic manufacturing operations to Salt Lake City, which we announced in July, is proceeding according to plan," he added. "The Novus Varia is the first new product to result from our Santa Clara research and development and Salt Lake City manufacturing teams. This new diode laser center of excellence has been made possible by the successful integration of last year's acquisition of HGM."
Retinal diseases are a leading cause of impaired vision and blindness. For example, 30 million people worldwide suffer from diabetic retinopathy and other diseases that can be treated with this system. Photocoagulators are used to treat a variety of retinal diseases, including age-related macular degeneration (AMD), proliferative diabetic retinopathy, retinopathy of prematurity, retinal tear and detachment, and retinal vein occlusion. The Novus Varia joins the Elite DPSS, Novus Omni multi-color, Novus 2000 argon and Ultima 2000 SE portable argon family of photocoagulators, as the newest addition to a complete line of ophthalmic lasers and accessories for ophthalmologists - treating the most challenging retinal diseases.