Trimedyne Inc. Reports FDA OK on Laser Trials
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Trimedyne Inc. said it has received Food and Drug Administration approval for human trials of its Optilase Laser System and Coronary Laserprobe as an adjunct to bypass surgery in treatment of atherosclerosis of the heart.
The trials will involve patients with heavy calcium build-up in their arteries, said a spokeswoman for the Santa Ana-based company.
The laser-heated Trimedyne catheter alone may not be enough to remove the calcium deposits in such arteries, but could be effective when used a part of a conventional bypass operation, the spokeswoman said.
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