Trimedyne Inc. in Irvine is hoping to spark the interest of the U.S. Food and Drug Administration in a laser procedure that it has already used overseas for the past 2 1/2 years to treat thousands of men afflicted with enlarged prostate glands.
The company said Monday that it has asked the FDA for permission to sell its so-called "Urolase" product in this country. The device employs a side-firing laser that cuts into the prostate and relieves pressure in the enlarged gland. It is estimated that more than half of all men over 55 suffer from the ailment, Trimedyne said.
The device was developed and is manufactured by Trimedyne, which makes lasers for orthopedic, urological and cardiovascular surgery. It is distributed overseas in Europe, South America and Asia by C.R. Bard Inc., a medical device company in Covington, Ga.
Marvin P. Loeb, Trimedyne's chief executive, said that he hopes to get FDA approval to market the device in the United States by next summer. The procedure of cutting through the enlarged prostate with a laser costs less than half the average $7,000 tab for cutting away blockage during traditional surgery.
The application follows more than a year's study, conducted by C.R. Bard, at six medical centers nationwide.