17 Jun 2002
The FDA has, for the first time, granted clearance for lasers to be used to treat Carpal Tunnel Syndrome.
The Food and Drug Administration has granted MicroLight, US, clearance to use its laser-based system to treat Carpal Tunnel Syndrome. This technique offers patients a non-invasive alternative to surgical procedures traditionally used to treat this repetitive stress syndrome.
The approved device is called the ML830 Cold-Laser system. Mike Barbour, president of MicroLight told Optics.org: "The ML830 contains four diode lasers. One laser operates at 640 nm and provides an 'aiming' beam before three near-infrared diode lasers emitting at 830 nm are switched on to provide treatment."
In one treatment, the three 830 nm lasers are on for 33 s in continuous-wave mode. A patient receives 10 individual and successive treatments in one session. "This gives a total of 3 J of energy incident on the skin per session. At these values, there is no heating at skin level," said Barbour.
The unit is portable and powered by a rechargeable nickel cadmium battery, similar to those in cell phones. The battery provides power for 33 separate treatments before it needs recharging.
MicroLight researchers and clinicians at the Baylor College of Medicine in Texas, US, have carried out a randomized double-blind trial to test the device. The trial lasted for 3 years and a total of 140 patients were involved. To date, the team has observed a 70% success rate.
The technique could also be suited to other soft tissue applications. Barbour explained: "We expect this will find uses in treating arthritis and tennis elbow for example, but we can only market the device for what the FDA has approved."
In the US, a licensed medical practitioner can offer this treatment if they attend a one-day training course and become certified. MicroLight lease the ML830 to practices for a monthly fee.
Author
Jacqueline Hewett is news reporter on Optics.org and Opto & Laser Europe magazine.
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