Trimedyne Acts to Market Arteriosclerosis Treatment

Santa Ana-based Trimedyne is seeking approval from the Food and Drug Administration to market its laser catheter device for treatment of arteriosclerosis of the legs.

The device, which has been clinically tested on more than 200 patients in the last 30 months, could sell for up to $700. Company officials declined to estimate the product’s potential market share.

Balloon catheter dilation, bypass surgery or leg amputation are now used to treat arteriosclerosis, which is caused by an accumulation of fatty deposits and plaque in the body’s arteries, which block blood flow to the legs, neck and heart.

The laser device works by either vaporizing or melting the buildup of plaque. The device is less expensive and requires a shorter recuperation, according to Richard Randall, Trimedyne vice president.

The product could produce significant sales for Trimedyne, but the company’s biggest potential for success will come with products that treat diseases in and around the heart, according to Pieter Halter, president of Biomedical Business International, a Tustin-based trade journal.

In July, Trimedyne became the first developer of laser devices to receive clinical trial approval from the FDA for non-surgical treatment of arteriosclerosis of the heart. In August, Trimedyne received FDA approval to market a medical laser system for non-surgical treatment of cancerous and non-cancerous pulmonary tumors.