FDA OKs Trimedyne Catheter for Leg Veins
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IRVINE — Trimedyne Inc. on Wednesday announced that it has received approval from the federal Food and Drug Administration to market its HaloCath laser catheter to remove fatty deposits from blood vessels below the knee.
The company, which manufactures laser systems for surgical and cardiovascular purposes, estimates that the laser may eliminate the need for many of the 100,000 leg bypass surgeries and 90,000 leg amputations that occur each year in the United States. However, Trimedyne did not estimate its potential sales of the laser catheter.
Trimedyne had previously received FDA approval to market a larger version of the HaloCath for use on blood vessels between the knee and the waist.
In preparation for marketing the new, smaller HaloCaths, the company will conduct a clinical study to further evaluate their effectiveness. The laser catheters are being tested in clinical trials for use in coronary arteries.
Despite the news, Trimedyne’s stock fell 12.5 cents in over-the-counter trading Wednesday, to close at $8.625.
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