Trimedyne Wins FDA’s OK for New Laser System

Trimedyne Inc. of Santa Ana said it has received Food and Drug Administration approval to begin marketing its Optilase-Yag laser system for treatment of tumors and other conditions involving blockage of the gastrointestinal and urological systems.

The Optilase-Yag, essentially a “black box” that generates the laser beam, is designed for use with Trimedyne’s patented Spectraprobe laser catheter, which received FDA approval earlier this month, said Michael Henson, Trimedyne president.

Marketing of the two devices is expected to get under way in January, Trimedyne said.

Henson estimated that the total market for the device as a treatment for gastrointestinal and urological disorders is between $30 million and $40 million a year. However, Henson said he did not know how much of that market his company can capture.