Trimedyne Wins FDA Approval for Catheter

Trimedyne Inc., a Santa Ana manufacturer of medical devices, said it has received federal Food and Drug Administration approval to market a laser catheter device to treat severe gastro-intestinal diseases, such as bleeding stomach ulcers and cancerous tumors.

The disposable catheter, called a Laser Probe-GI, comes in varying sizes and costs $200 to $300. Its companion machine, the Optilase Argon Laser System, provides the laser power for the catheter. The machine, which costs about $80,000, was approved by the FDA two months ago.

Michael R. Henson, Trimedyne’s president, said the two products will be sold in March only to a few medical centers that specialize in treating gastro-intestinal diseases. The hospitals likely will include several in Southern California, such as the UCLA Medical Center, he said. Formal market introduction will be in June.

He said the company does not expect a large commercial market for the two products, but plans to pursue FDA permission to market similar laser microsurgical devices for use in larger markets, such as treatment of cardiovascular, respiratory and urological diseases.

Last June, Trimedyne won FDA approval for testing another catheter device, its Laserprobe-PLR, for use in the non-surgical treatment of such cardiovascular conditions as arteriosclerosis, primarily in legs.

In 1984, Trimedyne’s Laser Optiscope became the first FDA-approved laser product to be used in human clinical trials as a possible alternative to the 200,000 bypass surgeries now performed each year in the United States.