Trimedyne Laser Gets FDA Panel’s OK
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Trimedyne Inc. of Santa Ana said its laser equipment for treating atherosclerosis of the legs has been recommended for U.S. Food and Drug Administration approval by the agency’s cardiovascular device panel.
The company’s devices--a catheter and a laser energy system--are the first laser devices approved by the FDA panel, said Michael R. Henson, president and chief executive.
Henson said final FDA approval is expected in 45 to 60 days. Trimedyne expects to be marketing the devices by June.
The devices, already in use in nine foreign countries and in trial use at 25 U.S. medical centers, represent a non-surgical method for getting to and vaporizing fatty deposits in leg arteries.
Trimedyne also is testing a similar system for treating atherosclerosis of the heart.
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