Cardima Awarded Patent for Surgical Ablation; 30th Patent Awarded to Cardima.Business Editors/Health & Medical Writers FREMONT, Calif.--(BW HealthWire)--Jan. 23, 2002 Cardima(R), Inc. (Nasdaq:CRDM CRDM Control Rod Drive Mechanism CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University) CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) ) -- developer of the REVELATION(TM) Tx microcatheter system and the REVELATION Helix(TM) microcatheter systems -- today announced the receipt of a patent for surgical ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. using radiofrequency energy for treating atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. (AF) and other cardiac conditions. The patent is for a device to be used by surgeons on the outside surface of the heart in a minimally invasive procedure Minimally invasive surgical procedures avoid open invasive surgery in favor of closed or local surgery with less trauma. These procedures involve use of laparoscopic devices and remote-control manipulation of instruments with indirect observation of the surgical field through an or during open chest operations. The patent covers specific claims for a deflectable device optimizing access and tissue contact, including irrigation irrigation, in agriculture, artificial watering of the land. Although used chiefly in regions with annual rainfall of less than 20 in. (51 cm), it is also used in wetter areas to grow certain crops, e.g., rice. through the device. "This patent award marks another milestone in our ongoing commitment to provide physicians with leading-edge technology for treating patients suffering from arrhythmias," said Gabriel Vegh, chief executive officer of Cardima. "By broadening our coverage with this patent, we can now expand our plan to market devices for treating atrial fibrillation to include cardiac surgeons." Cardima, Inc. developed the linear ablation REVELATION Tx system for treating AF. Since AF afflicts an estimated 2.3 million people in the U.S. and approximately 4.5 million people worldwide, the Company believes it is a potential $6 billion market that is poorly served by current treatment alternatives. The REVELATION Tx microcatheter system is a minimally invasive, single-use system for potentially curing AF, and is believed by the Company to be at least two years ahead of other development-stage ablation therapies ablation therapy See Ablation–cardiology. in the approval process. Phase I and II data with the REVELATION Tx microcatheter system demonstrated safety and promising efficacy. The Company is targeting approval for the REVELATION Tx by the end of calendar year 2002. The Company's REVELATION Helix received CE mark approval in December 2001 and has just commenced market launch in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community . Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include the Company's ability to raise additional capital, conduct successful clinical trials, obtain regulatory approvals and gain acceptance from the marketplace for its products. Additional risks are set forth in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. for the year ended December 31, 2000 filed with the Securities and Exchange Commission on March 22, 2001, and subsequent Form 10-Qs issued in 2001. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events. |
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