FDA CLEARED to treat & manage CTS.
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
ML830 "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. "TDA market clearance for the ML830 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 ML830 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 ML830's CTS application and to develop other clinical
applications for the ML830. "The ML830 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 earl
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, there 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 of gel (like ultrasound) to do
its work.
The ML830 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
metabolism 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 overall
reduction in healing time.
The ML830™ is a GaAlA Laser that has a wavelength of 830 nm with a power output of 90mW. At this wavelength and power the ML830™ Laser has a penetration of approximately 5 cm with a 3 cm lateral spread.
Ø FDA Cleared for
the treatment of CTS
Ø Patented
Technology
Ø Insurance
Reimbursable
Ø Non-invasive
Ø Reduces
Inflammation
Ø Stimulates Nerve
Function
Ø Backed by 12
years of Clinical Research