Moving a step closer to its goal of replacing traditional coronary bypass operations with less traumatic and less expensive laser surgery, Trimedyne Inc. said Tuesday that it has received U.S. Food and Drug Administration approval to use a laser-beam "scalpel" on humans in a test program being run at UCI.
The approval--which is applicable only for laser incisions made in the leg and neck areas--comes less than two weeks after the FDA approved Trimedyne's use of a laser to burn out plaque build-up in leg arteries.
Although the Santa Ana manufacturer of medical devices is the first of an estimated dozen competing companies to receive FDA approval for the two procedures, industry analysts say it may be five years before lasers will be sanctioned for use in the most critical area of all: the heart. Heart disease still ranks as the nation's leading killer.
Despite the analysts' caution, Michael R. Henson, Trimedyne president and chief executive, said the company's goal "is to begin using this equipment in the heart as soon as possible." Trimedyne, he said, could be "within months, not years" of achieving that goal. Henson also projected that some of the company's surgical laser equipment could be on the market within two years.
The new clinical study, which will use Trimedyne equipment and UCI's surgeons and patients, is the first phase of a UCI laser research program for the treatment of cardiovascular disease.
Industry executives estimate that bypass surgery in the United States currently costs the average patient in excess of $20,000 and requires up to 10 weeks for full recovery. Laser surgery, however, would cost about $6,000 and require only one or two weeks for recovery.
The competition to manufacture the laser equipment is fierce, as industry executives estimate that the market for laser instruments could exceed $100 million. Americans spend more than $4 billion annually on various forms of bypass surgery.
While analysts are intrigued by Trimedyne's progress, they are skeptical of the company's lofty goals. "They have an awfully optimistic view," said Larry Haimovitch, vice president at the San Francisco office of Swergold, Chefitz & Sinsabaugh, a New York-based investment banking firm. Haimovitch said years of research still are required to learn how to minimize the damage tremendously hot lasers can do to blood vessels while clearing out clogged arteries.
Despite the progress at Trimedyne, Henson said the company probably will lose $1 million this fiscal year--about half the $2-plus million it lost in fiscal 1984. By 1986, he projected, the company could be profitable, "But our first goal is to continue to invest money into R&D," he said.