TRIMEDYNE ISSUED U.S. PATENT ON NEW DEVICE TO
TREAT WIDESPREAD HEART VALVE DISORDER
9, 2004 – Irvine, CA: TRIMEDYNE, INC. (OTCBB “TMED”) today
announced the issuance of U.S. Patent No. 6,740,107, which
covers new, minimally invasive laser devices designed to treat
mitral valve regurgitation.
An estimated 4 million Americans suffer from this
year in the United States, approximately 50,000 people undergo
open-heart surgery to repair or replace a mitral valve.
In addition, an estimated 75,000 mitral valve repairs or
replacements are performed during bypass surgery.
In many people who have both mitral valve regurgitation
and heart failure, the condition is not treated, as they are too
ill to undergo surgery.
valve regurgitation or “prolapse” occurs when the valve does
not fully close and blood leaks backward into the left atrium
with each heartbeat, causing the heart to work harder, and
possibly leading to heart failure.
Traditional open-heart surgery requires the patient’s
chest to be opened, the heart stopped, a heart-lung machine to
be used, a 5 to 7 day hospital stay and a long recuperation
patent covers designs for two new laser devices to treat this
condition; one for use by surgeons during bypass surgery, and
one for use by cardiologists in the cath lab through a puncture
in an artery in the groin.
The device for use by surgeons will consist of a
patented, side-firing optical fiber encased in a balloon.
The balloon is designed to be inflated in the annulus or
“collar” of the valve. Laser energy is then emitted from the device as it is
rotated, like the beacon of a lighthouse.
The laser energy shrinks the annulus and the leaflets of
the valve, just as laser energy is used to shrink facial tissues
to treat wrinkles. The
device may also be positioned in the left ventricle to shrink
the tendons that close the valve, but which may become stretched
over time. The device is designed to significantly reduce the
surgical trauma of conventional valve repair or replacement.
device for use by cardiologists will consist of a catheter
designed to be inserted into the patient’s femoral artery and
positioned in the annulus of the mitral valve or the left
ventricle. In this
device, the balloon is intentionally made lop-sided, with the
side from which laser energy will be emitted significantly
larger in diameter than the opposite side.
When the balloon is inflated with a fluid opaque to
x-rays or ultrasound energy, the cardiologist can see the shape
of the balloon and determine the direction in which laser energy
will be emitted.
earlier acquired U.S. Patent No. 5,989,284, which covers the use
of laser, radiofrequency, electrical or microwave energy to
shrink the mitral valve. The
new patent covers specific devices designed for use with these
and other forms of thermal energy to treat mitral valve
regurgitation, expanding Trimedyne’s patent position in this
trials at substantial cost and FDA approval will be required
before any of the above devices can be marketed in the United
with modest sized clinical trials, such devices may be marketed
in Europe, when CE Marked, and most countries in Asia, the
Middle East and South America.
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-K-SB and subsequently filed SEC
reports. There is
no assurance such statements will prove to be accurate, and
actual results and future events could differ materially from
those anticipated in such statements.