Biostimulation: An Application Whose Time May Have Come

This article was published in the May 1994 issue of Medical Laser Report.

Biostimulation: An Application Whose Time May Have Come

Irving J. Arons
Managing Director
Spectrum Consulting

Biostimulation -- the use of low energy lasers to treat inflammatory conditions of the joints – and the FDA’s stance on this application, were the subject of a discussion by Richard Felton of the FDA during one of the morning sessions at this year's ASLMS meeting.

Felton defined biostimulation as the use of a low energy laser to produce physiological changes, either directly or indirectly, by non-thermal interaction of mono-chromatic radiation with a target site. Although this use of lasers provides a non-significant risk, the FDA's position is that specific applications will require the IDE/PMA route to marketing clearance. Felton went on to state that although a body of scientific evidence was being produced to show that low energy lasers do have a bio-effect on tissue, much of the evidence remains contradictive. Much of the human testing has been inconclusive, and further testing will be required to show reproducible endpoints and significant improvements/differences over conventional treatment modalities. He believes that 510 (k) clearance is problematical, with the need to show equivalence to pre-1976 devices. Thus, he believes that multi-center trials (at least three sites) with valid sample sizes will be required.

With this being said, however, we have learned that at least one company claims to have received a 510(k) approval for the use of infrared energy to provide therapeutic effects, and a second company, Lasermedics (Stafford, TX), who will participate in a medical symposium on June 15th in conjunction with General Motors, to announce the results of its controlled, double-blind program to treat carpal tunnel syndrome with its diode-laser based MicroLight 830 biostimulation laser, which the company hopes will lead to a 510(k) approval for the use of its device. Lasermedics reports that it obtained Canadian government approval for use of its device on humans in February. According to company officials, in the GM program the target group treated with the Microlight 830 laser showed significant improvements over those receiving the blinded non-laser treatment and those getting standard physical therapy normally used to treat the problem.

We will report on the results of the General Motors test program in our July issue.