THE
ML83O COLD LASER
One of the most fascinating and used healing advances is the
MicroLight 830 low-level laser. We are pleased to announce
that the MicroLight
830 has received FDA clearance for the treatment of Carpal Tunnel
Syndrome. The full
announcement of the MicroLight is as follows: HOUSTON (BUSINESS
WIRE)--Feb. 11, 2002--MicroLight Corporation of America announces
receipt of
market clearance from the Food and Drug Administration
for the company's ML83O "Cold Laser" for use in the non-surgical
treatment and management of carpal tunnel syndrome or "CTS."
"
CTS sufferers are now free to seek relief from hand and wrist pain
through a new non-invasive form of therapy before resorting to surgery," stated
Mike Barbour, president of MicroLight Corporation of America. "FDA
market clearance for the ML83O resulted from working with FDA examiners
over the past ten years to ensure continuing compliance with the law," says
Barbour. He estimates that more than $4 million was spent in this effort. "Our
ML83O successfully performed in several double blind studies and in
many clinical trials where some rather substantial parties were involved,
including Baylor College of Medicine and General Motors," he
added.
"
We are pleased that the FDA market clearance allows commercialization
of this important "cold" laser technology," stated Fred
A. Simpson, MicroLight's executive vice president. MicroLight Corporation
of America is seeking strategic partnerships to manufacture and market
the ML83O's CTS application and to develop other clinical applications
for the ML83O. "The ML83O has potential for other
soft tissue applications," says Simpson.
Carpal Tunnel Syndrome is the number one repetitive stress injury
in America today and is a leading cause of worker lost time and
disability. More than one million Americans acquire CTS symptoms
each year, and over 200,000 surgical procedures are performed in
the treatment of CTS at an annual cost of over $10 billion. Private
insurance companies and governmental health plans bear most of
that cost.
Although CTS can begin suddenly, its onset is usually gradual.
If not treated, CTS may lead to reduced hand function with possible
permanent nerve and muscle damage. With early diagnosis and treatment,
however, complete recovery usually occurs. Anything that causes
swelling of the synovium that surrounds wrist tendons, or produces
repeated pressure on the median nerve, can lead to CTS or make
it worse if the condition already exists. It should be mentioned
that when a medical drug or device is approved for use with a particular
condition (this is the usual FDA procedure),
the doctor has the option of using it for other conditions if in
his medical opinion, it is indicated. While the FDA has cleared
the device for Carpal Tunnel Syndrome treatment, their are many
other exciting possibilities for this device, which should be available
in the near future, through future clinical studies.
In our experience the MicroLight 830, which has been affectionately
called "the world's most expensive flashlight," has
a multitude of uses. Perhaps the most appealing single factor
about
this unit is the possibility that it may help conditions
where all previous therapies have failed. We are certain
you can
readily see how such an attribute would endear this unit
to any dedicated
practitioner. Besides this, it is small (will fit into a
coat or pants pocket), portable (since it is battery operated),
will work
through light clothing and requires no special creams or
gel
(like ultrasound) to do its best.HOW DOES THE ML83O WORK?
ML83O Laser is a non-thermal laser capable of penetrating deep
into tissue. Once delivered, the light energy promotes the process
of photobiostimulation. In human tissue the resulting photochemical
reaction produces an increase in the cellular meta-bolism rate
that expedites cell repair and the stimulation of the immune, lymphatic
and vascular systems. The net result, observed in clinical trials
to date, is the apparent reduction in pain, inflammation, edema
and an over all reduction in healing time.