Cardima Reports Favorable Revelation Tx Preliminary Phase III Clinical Data.Business Editors & Health/Medical Writers FREMONT, Calif.--(BW HealthWire)--June 13, 2002 Six Month Follow-up Data Shows 97% of Patients Report Reduced 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) Episodes; 50% Report No Recurrence of AF Episodes 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 and REVELATION(TM) Helix(TM) microcatheter systems, today announced preliminary data from its REVELATION Tx Phase III clinical trial Noun 1. phase III clinical trial - 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 for the treatment of atrial fibrillation (AF). Preliminary 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 data indicate that 97% of the patients had a greater than or equal to 50% reduction in their AF episodes, and 50% of the patients reported no recurrence of AF episodes. The data represents a compilation of results from six-month follow up of 45 patients who had previously failed two levels of anti-arrhythmic drug therapy and had documented episodes of AF in the 30-day baseline monitoring period. The patients were treated with the REVELATION Tx at 18 investigational sites in the U.S. The Phase II study indicated that, at six-month follow up, 87% of the 37 patients had a greater than or equal to 50% reduction in their AF episodes, and 48% of the patients reported no recurrence of AF. Results of this study were reported in April 2001. Cardima expects to complete the necessary six-month follow up of all patients enrolled in the REVELATION Tx Phase III study in June 2002 and plans to submit, in the third quarter of this year, a pre-market approval (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 ) application seeking U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) approval of REVELATION Tx for the treatment of AF. "Data collected from the Phase III study further supports our belief that the REVELATION Tx microcatheter system can be a vital tool in the treatment of AF," said Gabriel Vegh, Chief Executive Officer of Cardima. "We believe that the REVELATION Tx is the only device for treating AF currently in Phase III clinical trials and we are targeting FDA approval of the REVELATION Tx by the end of this year," continued Mr. Vegh. "We are also encouraged by the continued confidence and positive experience physicians participating in the Phase III study are reporting after using the REVELATION Tx to treat their patients," added Mr. Vegh. Cardima, Inc. developed the linear ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. REVELATION Tx and REVELATION Helix systems for treating AF. Since AF afflicts an estimated 2 million people in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. 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 with the potential of curing AF, and is believed by the Company to be at least two years ahead of other development-stage ablation therapies in the approval process. Phase I and II data with the REVELATION Tx microcatheter system have demonstrated safety and promising efficacy. The Company is targeting FDA approval for the REVELATION Tx by the end of calendar year 2002. The Company's REVELATION Helix received CE mark approval in December 2001 with initial 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 in the first quarter of 2002. 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, 2001, Quarterly Reports on Form 10-Q Form 10-Q See 10-Q. and other reports filed with the Securities and Exchange Commission. 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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