Trimedyne to Seek FDA’s Approval of Laser Treatment
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IRVINE — Trimedyne Inc. said Thursday that it will seek U.S. Food and Drug Administration approval to market its Holmium “cold” laser to treat spinal disk problems.
The procedure can relieve pressure on spinal nerves, reducing lower back pain, the company says. Trimedyne says the cold-laser procedure is less costly and requires less recuperative time for patients than traditional spinal disk surgery.
Cold lasers are preferable to thermal laser treatments for the same condition, the company claims, because thermal lasers can char the tissue surrounding the spine, causing inflammation and delays in healing.
The Holmium laser is called “cold” because it is able to vaporize tissue without thermal damage to adjoining cells.
The cold laser is currently approved for removing fatty blockages from blood vessels below the waist, to treat knees and other joints, and in surgery on the gallbladder, stomach and other organs.
The Holmium laser sells for between $120,000 and $140,000. A small number have been sold to medical centers, which are generating clinical data, said Hany Hussein, executive vice president of Trimedyne.
The company also makes and sells the Excimer cold laser, which is gentle enough on nearby tissue to unblock heart arteries, and the Nd:YAG thermal laser.
Trimedyne’s stock, which is traded over the counter, closed Thursday at $6.375 a share, up 37.5 cents.
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