Trimedyne Gets FDA Approval to Market Cold Laser

Trimedyne Inc., a medical laser catheter manufacturer struggling to revive flagging sales, said Monday that it has received approval from the Food and Drug Administration to market the first so-called “cold laser” for opening blocked arteries of the legs.

Trimedyne in 1987 was the first company to win the FDA’s approval to market a laser-powered “hot-tip” catheter to sear through fatty plaque in leg arteries. The hot laser uses laser energy to heat the metal tip of a catheter, which is then threaded through the arteries to vaporize the blockages.

But sales of the hot laser fell off when the medical community expressed preference for an alternative technology known as a “cold laser.” A cold laser uses a free beam of laser-produced light, administered in short bursts, to remove the plaque without producing significant heat. Doctors prefer it because they want to eliminate the possibility of thermal damage to healthy tissues.

While Trimedyne’s hot laser has shown success in opening clogged leg arteries, the FDA has not yet approved it for use in the heart. The market for using lasers to unblock clogged heart arteries is estimated by Trimedyne to be worth up to $800 million a year.

Trimedyne began developing a cold laser about two years ago.

Richard Demmer, Trimedyne’s executive vice president, said his company’s Omni-Pulse laser, approved by the FDA, is powered by a holmium crystal that generates short bursts of ultraviolet light to vaporize plaque.

“The medical world has said the cold laser is the way to go and now we have met the challenge,” he said.

However, Demmer said it’s too soon to tell if the cold laser will prove superior to the company’s hot laser in treating blood vessel blockages in the legs.

Trimedyne’s main objective, he said, is to get the cold laser approved for cardiac use, although he acknowledges that the process will likely take two years. Another local firm, Advanced Interventional Systems of Irvine, is expected to become the first U.S. company to get federal approval to market a cold laser to treat blocked coronary arteries.

An FDA medical panel recently approved the AIS device for use as an alternative to bypass surgery in certain cases when balloon angioplasty--forcing an opening with pressure--had been uneffective in clearing a patient’s heart arteries.

Trimedyne lost $6.2 million on revenue of $10.2 million for the first nine months of its fiscal 1990 year, contrasted with earnings of $929,000 on revenue of $26.6 million for the corresponding year-earlier period.