Trimedyne Gets Approval to Expand Catheter Tests
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Trimedyne Inc. of Santa Ana said it has received permission from the Food and Drug Administration to expand human testing of its coronary laser catheter for the non-surgical treatment of heart atherosclerosis.
The process pioneered by Trimedyne is considered an alternative to heart bypass surgery.
Trimedyne began testing its laser catheter on humans in August, 1986, at Boston University Hospital. With the latest approval, the tests--expected to last six to nine months--will be expanded to three major cardiovascular hospitals in the United States.
The company already has received FDA approval to sell the laser catheter to treat leg atherosclerosis, also known as hardening of the arteries.
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