Trimedyne Inc. said Wednesday that it has received federal approval to begin clinical testing of a new catheter with its Holmium “cold” laser that it hopes will open blocked arteries of the legs and heart more effectively than predecessor models.
Trimedyne officials said the U.S. Food and Drug Administration has given it a go-ahead to begin testing the device, called a Halo Spectracath, in the legs. And they said within the next three months the company expects to receive FDA approval to start testing a smaller and more flexible version of the device in the sensitive arteries of the heart.
M.G. Hussein, Trimedyne’s executive vice president of research, said the company’s new catheter is designed so that it will emit a halo of laser energy from almost its entire face, which is one-eighth of an inch in diameter. He said that cutting energy is produced by as little as 10% of the faces of other catheter models,
As a result, Hussein said, the new catheter, when threaded through an artery, is expected to bore a larger channel through plaque to improve blood flow. He said it is also hoped that the Halocath can be used alone, eliminating the need to also use “balloon catheters” that expand to break plaque. By causing less damage to artery linings, he said, the Halocath may lower the incidence of repeat blockages.
Trimedyne officials said the Halocath will be tested at 10 universities and medical centers in the United States and several others in Europe to obtain data required to apply to the FDA for approval to market the device in this country. They said the device will be tested on the legs of about 75 patients and, pending FDA approval, on 200 heart patients.
Development of the Halocath is part of Trimedyne’s campaign to break into the “cold” laser field. In 1987 the company became the first in the country to obtain FDA approval of a system that uses laser heat to sear through blockages in leg arteries. But a short surge of sales came to an abrupt halt when it became clear that it would be difficult for Trimedyne to obtain approval to use the device in the heart.
So the company turned to developing a cold laser that produces energy in short pulses that can cut through plaque without creating the intensity of heat which, it is feared, can cause damage in the heart.