Mitral 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 period.

       Trimedyne’s 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.

       The 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.

       Trimedyne 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 field.

       Clinical trials at substantial cost and FDA approval will be required before any of the above devices can be marketed in the United States.  However, 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.

       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-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.