Trimedyne’s Laser to Unclog Arteries Approved by FDA

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

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 arteries to vaporize blockages.

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

Although Trimedyne’s hot laser has shown success in opening clogged leg arteries, the FDA has not 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. The Trimedyne Omni-Pulse laser approved by the FDA is powered by a holmium crystal that generates short bursts of ultraviolet light to vaporize plaque, said Richard Demmer, Trimedyne’s executive vice president, who added, “The medical world has said the cold laser is the way to go, and now we have met the challenge.”

Demmer said it is 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 probably take two years.

Another Southern California 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.

A FDA medical panel recently approved the AIS device as an alternative to bypass surgery in certain cases when balloon angioplasty--forcing an opening with pressure--is ineffective 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 year-earlier period.