Trimedyne Inc. of Santa Ana has received approval from the U.S. Food and Drug Administration to market one of its medical laser systems to hospitals for the treatment of atherosclerosis of the legs.
The approval increases the potential market for the system by making it usable in treating a number of ailments. Company officials said almost 1,200 hospitals--representing potential annual sales of $200 million, double the current market--could purchase the laser.
Until now, the system had been authorized for use mainly in treating gastrointestinal tumors, and certain pulmonary and gynecological diseases and urological disorders.
Trimedyne's laser technology allows doctors to destroy tumors and create openings in clogged arteries by vaporizing the fatty blockage caused by atherosclerosis, thus restoring blood flow to the lower legs and feet.
Richard Randall, Trimedyne's vice president of marketing, said the latest FDA action makes the laser more readily available to community hospitals for the treatment of cardiovascular diseases such as atherosclerosis.
Two other Trimedyne lasers were approved last March solely for the treatment of atherosclerosis, Randall said, and were marketed primarily to the nation's 720 largest cardiovascular centers, which could afford such limited-use equipment.
But about 400 smaller hospitals that treat some cardiovascular diseases did not have access to laser technology for the treatment of atherosclerosis in the legs because of the cost and limited usefulness of the machine.
Trimedyne's entire product line has been in development for more than five years at an estimated cost of $8 million.