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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