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TRIMEDYNE LASER USED IN OUTPATIENT PROCEDURE
TO TREAT ARTHRITIS IN SPINAL JOINTS
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October
11, 2004 – Irvine, CA: TRIMEDYNE, INC. (OTCBB “TMED”)
today announced that a clinical study published in the Journal
of Minimally Invasive Spinal Technology demonstrates the ability
of Trimedyne’s Holmium Laser to treat osteoarthritis in lumbar
(lower back) facet joints in the spine, a common cause of low
back pain.
Twenty
patients with arthritis of the facet joint were treated on an
outpatient basis by Sri Kantha, M.D., of the Metropolitan
Neurology and Spine Institute, Fort Lee, NJ.
All of the patients were discharged the same day, with
pain medication, muscle relaxants and no restrictions on
physical activity. Fifteen
or 75% of the patients reported significant or partial relief of
their lower back pain. In
the remaining five patients (25%), their back pain was the same
as before the procedure. Older patients did not respond as well as younger patients.
According
to Dr. Kantha, “At least one million people in the United
States who suffer from lower back facet joint pain could be
successfully treated with the new laser procedure, technically
called Laser Lumbar Facet Rhizotomy.
The one-year results of Laser Lumbar Facet Rhizotomy
reported in the above paper are superior to procedures using
radio frequency (RF) energy, as the laser is more precise, and
its pain-relieving effect lasts for years.”
Trimedyne
plans to submit this clinical study to the FDA, along with an
application for clearance to market its Holmium Laser and
disposable Laser Needles for this use.
These devices will not be available for sale for the
treatment of arthritis in lumbar facet joints in the United
States until and unless they are cleared for sale by the FDA for
the treatment of this condition.
Trimedyne
manufactures lasers and proprietary fiber optic devices for a
variety of minimally invasive surgical procedures, many of which
are performed on an outpatient basis at substantially less cost
than conventional surgery.
For product, financial and other information, visit
Trimedyne's website, http://www.trimedyne.com.
"Safe Harbor" Statement
Under the Private Securities Litigation Reform Act:
Statements in this news release may contain
forward-looking statements within the meaning of Section 27A of
the U.S. Securities Act of 1993 and Section 21E of the
Securities and Exchange Act of 1934.
Such statements may involve various risks and
uncertainties, some of which may be discussed in the Company's
most recent report on Form 10-KSB and subsequently filed SEC
reports. There is
no assurance any new products can be cleared for sale by the FDA
or successfully commercialized or any forward-looking statements
will prove accurate, as actual results and future events could
differ materially from those presently anticipated.
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