Cardima Awarded Patent for REVELATION Tx and Linear Ablation Method.Business Editors & Health/Medical Writers FREMONT, Calif.--(BW HealthWire)--June 26, 2001 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 for the treatment of 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), today announced that it has been awarded U.S. patent 6,251,107 for the REVELATION Tx, encompassing the product and its linear ablation method. "This patent protects two important aspects of our technology," commented Gabriel Vegh, chief executive officer of Cardima. "First, we received this patent for the unique design of the REVELATION Tx microcatheter which includes small, coiled electrodes designed to conform to Verb 1. conform to - satisfy a condition or restriction; "Does this paper meet the requirements for the degree?" fit, meet coordinate - be co-ordinated; "These activities coordinate well" atrial atrial /atri·al/ (a´tre-al) pertaining to an atrium. a·tri·al adj. Of or relating to an atrium. Atrial Having to do with the upper chambers of the heart. tissue and to create narrow ablation paths with much less energy, preserving more tissue. "Second, the patent includes claims for a method of linear ablation, which allows a physician to perform minimally invasive linear surgical cuts, saving cost and replacing a highly invasive, open-chest procedure." The company's Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA clinical study to treat paroxysmal paroxysmal (per´ adj recurring in paroxysms. atrial fibrillation using the REVELATION Tx began in September 2000 and will supplement the Phase II data with up to an additional 80 patients being treated at up to 20 U.S. centers. Phase II data showed 48% of the patients treated were free from AF and 87% of the patients had greater than or equal to a 50% reduction in their AF episodes six months after treatment with the REVELATION Tx. Patients enrolled in this Phase III trial must have failed two levels of prior drug therapy and will be monitored for six months after their treatment with the REVELATION Tx system for submission of the PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy . Cardima Inc. developed the REVELATION Tx system for the treatment of AF, which the company estimates is a potential $6 billion market that is poorly served by current treatment alternatives. AF afflicts an estimated 2.2 million people in the U.S. and approximately 4.5 million worldwide. The REVELATION Tx system is a minimally invasive, single-use, microcatheter-based product for potentially curing AF, and is believed to be 2-3 years ahead of other development-stage ablation therapies in the approval process. Phase I and II data with the REVELATION Tx system demonstrated safety and promising efficacy; enrollment in the Phase III study is underway. Except for the historical information contained herein, the matters discussed in this news 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 Dec. 31, 2000, and Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2001, filed with the Securities and Exchange Commission on March 22 and May 14, 2001, respectively. 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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