FDA Approves Human Tests for Trimedyne Artery Laser

Trimedyne Inc. said Tuesday that it has received approval from the U.S. Food and Drug Administration to conduct human tests on its holmium cold-laser system to clear clogged heart arteries as an alternative to bypass surgery.

The Tustin-based biotechnology company said it successfully tested the laser system last week at the Northern Sheffield Hospital in England. It expects to expand its studies to more than 10 medical centers worldwide, including Fountain Valley Regional Hospital and Medical Center.

The news of the FDA approval gave the company’s stock a boost Tuesday. The stock closed up 37.5 cents Tuesday, closing at $2.25 in over-the-counter trading. Still, Trimedyne stock is off 67% from its yearly high of $6.75 achieved in January.

Trimedyne, which pioneered the use of laser-assisted catheters to open blocked arteries, in 1987 was the first company to win FDA approval to use lasers in leg surgery.

Its technology then was a “hot-tip” laser that used heat to vaporize plaque or fatty deposits in arteries. That hot laser, however, could damage the artery.

Cold lasers have since been used to cut through the plaque with short bursts of ultraviolet light, which do not produce the heat of hot lasers.

Trimedyne’s cold laser uses holmium, a rare metal element used to control the wavelengths of highly focused laser light.

FDA spokeswoman Susan Cruzan said it normally takes more than two years for a company to test a medical device and get final approval. Trimedyne is just one of several companies that received FDA approval to test the cold laser for coronary application, she said.

Other companies include Irvine’s Advanced International Systems Inc., Spectronetics Corp. of Colorado Springs and Eclipse Surgical Technologies Inc. of Mountain View in Santa Clara County. GV Medical Inc. of Minneapolis said it expects approval for similar tests later this year.

“The company hopes to use this new device to re-establish itself as a leader in laser angioplasty,” said Chriss W. Street, managing director of Reorganized Securities Corp. in Los Angeles.

He added that if approved by the FDA, the device could move Trimedyne to the forefront of this increasingly popular method of correcting coronary artery problems, short of heart surgery.