FOR IMMEDIATE RELEASE: Health Canada approves IntraLase FS
January 19, 2005

IntraLase Corp. has announced that Health Canada has granted a device license amendment for the commercialization of its INTRALASE FS laser

Following this approval, the California-based company intends to immediately commercialize this product in Canada. The Canadian distributor will be Sigmacon, a North York (Ontario) company that specializes in diagnostic and laser surgery equipment.
INTRALASE FS replaces the hand-held blade that has been traditionally used for creating a corneal flap in the first step of LASIK surgery. Unlike the microkeratome blade used to cut a flap across the cornea, the INTRALASE FS laser creates the flap below the corneal surface, working from the inside out.

The INTRALASE FS’s high-speed laser uses an infrared beam to separate tissue at the molecular level by precisely placing thousands of microscopic bubbles in a specific layer of the cornea. The flap is then completed by stacking these tiny bubbles along the edge of the flap up to the corneal surface. The surgeon uses a computer interface to pre-program the individual patient’s flap specifications. The complete IntraLase process takes approximately 45 seconds.

Canada is now the 18th country to approve the INTRALASE FS. By September 30th, 2004, 180 units had been installed in ophthalmic practices worldwide, and to date more than 250,000 of these procedures have been sold worldwide.

Clinical studies show that the INTRALASE FS laser makes LASIK procedures safer, significantly decreasing the risk of complications linked to the use of blades, such as invasive corneal incisions, corneal abrasions, "button-hole" cuts and poorly formed flaps. This new technology also greatly reduces the likelihood of producing the flap thickness variations that can lead to serious complications. Moreover, studies also show that patients see better when the INTRALASE FS technology is used for LASIK procedures than when blades are used.




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