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IRIDEX Announces FDA 510(k) and CE Clearance of New Laser Delivery System for Fast, Non-invasive Treatment of Serious Retinal Diseases
Date:12/3/2012

MOUNTAIN VIEW, Calif., Dec. 3, 2012 /PRNewswire/ -- IRIDEX Corporation (NASDAQ: IRIX) today announced the FDA 510(k) and CE clearance of the TxCell Scanning Laser Delivery System.  The new product saves significant time in a variety of laser photocoagulation procedures in allowing physicians to deliver the laser in a multi-spot scanning mode, a more efficient method for these procedures than the traditional single spot mode.  

"Broadening market acceptance for medical technologies typically involves effective clinical results, ease of use for the physicians and more efficient use of time.  TxCell can deliver all three benefits and is an important step in accelerating the adoption of our proprietary MicroPulse technology as it applies to several clinical procedures," stated Will Moore, IRIDEX President and CEO. 

Giovanni Staurenghi, MD, Professor of Ophthalmology and Chairman of the Eye Clinic Ospedale Sacco at the University of Milan was the first to use the new system.  Prof. Staurenghi stated, "TxCell Scanning Laser Delivery System with the IQ 577 offers an intuitive and versatile way to deliver several advanced laser modalities."

The TxCell Scanning Laser Delivery System combined with an IRIDEX IQ 532 or IQ 577 laser enabled with MicroPulse is designed to provide the ophthalmologist a highly versatile system with three laser modalities – multi-spot scanning, single spot standard, and MicroPulse Laser Therapy. Initial shipments have commenced with orders from a number of different countries.

About MicroPulse Technology
MicroPulse is a Fovea-friendly tissue-sparing laser delivery therapy that works by electronically "chopping" the laser emission into trains of microsecond pulses. This enhances the physician's ability to more precisely control the laser effects on tar
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SOURCE IRIDEX Corporation
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