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Lumenis Receives US FDA and Japanese MHLW Clearance for Array(TM) LaserLink(TM) Pattern Scanning Device for Multi-Spot Retinal Laser Treatment


November 15, 2013 - SAN JOSE, CA

Lumenis Ltd., the world's largest medical laser company for ophthalmic, surgical and aesthetic applications, today announced that the company has received US FDA and Japanese MHLW clearance for its Array™ LaserLink™ pattern scanning device for multi-spot laser photocoagulation. The Array LaserLink expands the capabilities of the Lumenis laser system to deliver pattern scanning capabilities, aimed to provide greater predictability in retinal treatments and presumably less collateral damage to the retina. The Array LaserLink is also projected to save treatment time for clinicians and reduce patient discomfort with designed shorter pulse duration and sequential multi-spot delivery resulting in shorter laser sessions.

"The introduction of the Array LaserLink device in the United States and Japan demonstrates and reaffirms Lumenis' ongoing commitment to developing and introducing advanced ophthalmic laser products and delivery devices that grow with our customers' needs," said Kfir Azoulay, Vice President & General Manager of the Ophthalmology Strategic Business Unit at Lumenis. "We believe Array will bring important benefits both to patients, clinicians and health care providers; and we look forward to working with the ophthalmology community to integrate our next generation technology into clinical practice. This milestone, along with other products in our pipeline will allow Lumenis to further enhance our leadership position in the global ophthalmic laser market in general and the retina segment in particular."

The Array LaserLink device adapts an examination slit lamp for use as a therapeutic laser delivery device. When attached to a compatible Lumenis photocoagulator the device offers a variety of features that significantly expand the capabilities of the Lumenis laser system. Treatment parameters and micromanipulation are all controllable from a remote touchpad designed to enhance the physician's workflow and efficiency. The touchpad allows the doctor to maintain visualization of the patient's retina through the slit lamp while changing treatment parameters such as spot size, spacing, number of spots in the pattern, pattern rotation and laser power. The Array's heads-up display shows confirmation of parameter changes, which are seen as text projected onto the retina.

The Array LaserLink device is indicated for the variety of ophthalmic uses specified for the laser to which it is attached, including diabetic retinopathy, choroidal neovascularization, branch retinal vein occlusion, retinal tears and detachments. With the Array LaserLink device, compatible Lumenis lasers systems will be augmented with the following features:

  • Multi-spot patterns
    Array provides a choice of laser patterns, permitting the doctor to select the application that is appropriate for the pathology and anatomy of the patient.

  • Multi-wavelength compatibility
    Array is able to deliver the wavelengths of the laser system to which it is attached, allowing the doctor to select the preferred wavelength for the specific case and even change wavelength during the treatment if desired. Array can deliver 532nm and 577nm wavelengths in scanning mode and 532nm, 577nm and 659nm in single spot mode.

  • Continuous Variable Spot Size
    Array offers Continuous Variable Spot Size from 50 to 1000 micrometers, allowing the doctor to customize treatment for the disease state and tissue response.

  • Variable distance between spots
    The distance between spots in a pattern can be set up to three times the diameter of the spot, giving the doctor the flexibility to adjust the pattern to suit the retinal condition.

The Array pattern scanning LaserLink device will be featured in the Lumenis booth (booth # 2144) at the American Academy of Ophthalmology Annual Meeting, taking place November 16-19 in New Orleans, Louisiana.

About Lumenis
Lumenis is a global leader in the field of minimally-invasive clinical solutions for the Surgical, Ophthalmology and Aesthetic markets, and is a world-renowned expert in developing and commercializing innovative energy-based technologies, including Laser, Intense Pulsed Light (IPL) and Radio-Frequency (RF). For nearly 50 years, Lumenis' ground-breaking products have redefined medical treatments and have set numerous technological and clinical gold-standards. Our drive for innovation stems from an uncompromising commitment to improving the health and well-being of our patients; addressing new and growing needs of aging populations and in offering medical professionals cutting-edge solutions that fit seamlessly into the health-economics environment of the 21st century. The world over, we bring Energy to Healthcare. For more information visit: www.lumenis.com.

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Contact information:
Jeff Jacomowitz for Lumenis
(212) 867 1762
jrjacomowitz@lazarpartners.com

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