IRVINE, Calif., March 4, 2004 (PRIMEZONE) -- Trimedyne, Inc. (OTCBB:TMED) today announced the U.S. Patent Office has allowed 17 claims of its patent application on a new Laser Balloon Catheter intended to treat mitral valve prolapse in a minimally invasive procedure. The patent should issue in a few months.
Mitral valve prolapse occurs when the leaflets of the mitral valve of the heart fail to close properly. Approximately 125,000 people undergo surgery to treat this condition each year in the United States, and many live with the condition because they do not wish to suffer the trauma and risk of death of the surgical procedure.
Lasers are widely used to shrink facial tissues to reduce or remove wrinkles. The laser energy passes through the upper layers of the skin, which is commonly cooled by a refrigerated fluid, and shrinks the underlying tissues. In laboratory tests, the proper wavelength and amount of laser energy was able to shrink the chordae tendonae, long tendons of cartilage which close the leaflets of the mitral value, up to 30%. While the patent application also covers high intensity light, radiofrequency (RF), microwave, electrical and ultrasound energy, the Company believes the uniform penetration of laser energy will cause a longer lasting shrinkage effect.
Trimedyne's Side-Firing Laser Balloon Catheter is designed to be used either by surgeons during bypass surgery or Cardiologists by advancing it through the arterial system to the heart from a tiny incision in the groin. The balloon may be filled with a cold fluid to cool the tissue while laser energy is applied to shrink it. Clinical trials of these devices will be required to obtain FDA marketing approval, the success of which cannot be assured.
Trimedyne earlier acquired an issued U.S. Patent covering the principle of applying thermal energy to shrink the chordae tendonae of the mitral valve. The new patent expands Trimedyne's proprietary position in this area.
Trimedyne is a leading manufacturer of surgical lasers and proprietary fiber optic devices for use in 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 at 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.