Ellex Receives FDA 510(k) Clearance for Industry's First Solid-State Red/Green Photocoagulator
11 Abril 2006 - 6:20PM
Business Wire
Ellex Medical Lasers Ltd. (ASX:ELX), a world leading designer and
manufacturer of laser systems for the ophthalmic industry,
announced today that it has received 510(k) clearance for the
Integre Duo, the world's first solid-state red and green
photocoagulator. The Integre Duo utilizes a patent-pending,
dual-wavelength laser cavity enabling ophthalmologists to better
treat challenging retinal conditions, often caused by age or
diabetes. Peter Falzon, Ellex' CEO, commented "We have responded to
our customers desire to integrate the clinical utility and
performance of the existing ion argon-krypton lasers in a
solid-state laser. The Integre Duo provides the benefits of both:
simultaneous true red and green wavelength selection in a compact
solid-state design." The Integre Duo was presented to the
ophthalmic community in March at the ASCRS meeting in San
Francisco, CA, and compliments Ellex' comprehensive line of lasers
for cataract, glaucoma and retina treatments and is expected to
contribute to the growing revenue base of Ellex branded systems.
The Integre Duo has already been approved for sale in Japan where
the first customer units will be installed in April. Ellex expects
the first customer units to arrive in the US market in July. Today,
two thirds of the company's revenue is derived from new products
released in the past three years as a result of recent investments
in product development and distribution solely focused on
ophthalmology. About Ellex Ellex Medical Lasers Ltd. (ASX:ELX)
designs, manufactures and markets a complete line of lasers used by
ophthalmologists to preserve vision and treat eye diseases. With
more than 10,000 systems delivered to the market, Ellex has evolved
since 1985 from a manufacturing company of primarily OEM products,
to direct marketing of its own branded products through
subsidiaries in the United States and Japan and a network of
distribution partners in more than 50 countries. Ellex maintains a
strong emphasis on intellectual property and research into new and
better treatments to manage and treat the leading causes of
blindness. For additional information about Ellex and its products,
please visit www.ellex.com
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