Cardima Announces Completion of Revelation Helix Study in Germany.Business Editors & Health/Medical Writers FREMONT, Calif.--(BW HealthWire)--June 4, 2002 Cardima(R), Inc. (Nasdaq SC: 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 completion of its clinical study in Germany with the REVELATION Helix radiofrequency (RF) ablation microcatheter 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) originating in the pulmonary veins of the heart. The study involved 40 patients who were treated at five German electrophysiology centers. Results of the study will be presented at the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. meeting in November 2002. "We are pleased with the effectiveness of the REVELATION Helix in isolating the pulmonary veins and the absence of pulmonary vein stenosis stenosis /ste·no·sis/ (ste-no´sis) pl. steno´ses [Gr.] stricture; an abnormal narrowing or contraction of a duct or canal. ," said Gabriel Vegh, Chief Executive Officer of Cardima, Inc. "Based on the encouraging results of this trial in Germany, we plan to apply for an investigational device exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and (IDE) for the REVELATION Helix in the U.S. and begin a clinical study in the second half of this year." The most advanced of the REVELATION microcatheter family, the REVELATION HELIX received CE mark approval in the EU in December 2001. Cardima began marketing the REVELATION Helix in the EU through direct sales and independent distributors in early January 2002. Cardima, Inc. developed the linear ablation REVELATION Tx and REVELATION Helix systems for treating AF. Since AF afflicts an estimated 2 million people in the United States 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 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 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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