Cardima Symposium At NASPE Shows Patient Outcome Improvements and Procedure Safety With REVELATION Series.Business Editors & Health/Medical Writers FREMONT, Calif.--(BW HealthWire)--May 15, 2002 Standing-room only symposium showcases REVELATION series for treatment of AF 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 -- announced today that the most recent developments in 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) treatment using the REVELATION family of microcatheters were presented at a scientific breakfast symposium in conjunction with the 23rd Annual Scientific Session of the North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. Society for Pacing and Electrophysiology (NASPE NASPE National Association for Sport and Physical Education NASPE North American Society of Pacing and Electrophysiology NASPE National Association of State Personnel Executives ) conference. Cardima's scientific breakfast symposium, "Advances in RF Linear Ablation," was held on May 10, 2002, in San Diego, California “San Diego” redirects here. For other uses, see San Diego (disambiguation). San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951. . The Cardima symposium was chaired by one of the pioneers in electrophysiology, Warren M. Jackman, M.D., Professor of Medicine and Director of Clinical Electrophysiology, University of Oklahoma University of Oklahoma, abbreviated OU, is a coeducational public research university located in the U.S. state of Oklahoma. Founded in 1890, it existed in Oklahoma Territory near Indian Territory 17 years before the two became the state of Oklahoma. , and featured recognized speakers from prestigious centers for electrophysiology. Panel member Dr. Abraham Kocheril, Head, Cardiac Electrophysiology, Associate Professor of Medicine of the University of Illinois University of Illinois may refer to:
adj recurring in paroxysms. AF patients. "Results of the REVELATION Tx Phase II portion of the Cardima clinical trial showed 87% of the patients had a greater-than or equal-to 50% reduction in AF. Even more significant, 48% had no AF at the six-month trial interval," said Dr. Kocheril. "I have conducted my own separate study with patient-specific mapping which has yielded 79% of my patients with no AF after 19.7 months, with no anti-arrhythmic drugs. These findings were published in the Journal of Interventional Cardiac Electrophysiology in December 2001. We are anxious to have the REVELATION Tx approved so others can use this important technology to improve the lives of those who suffer from this debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction disease." Priv. Doz. Dr. med. Thorsten Lewalter, Medizinische Klinik und Poliklinik II, University of Bonn The University of Bonn (German: Rheinische Friedrich-Wilhelms-Universität Bonn) is a public research university located in Bonn, Germany. Founded in 1818 the University of Bonn is nowadays one of the largest universities in Germany. , Germany, presented initial clinical data from the German multi-site clinical trial using the REVELATION Helix. Dr. Lewalter also presented an excellent preliminary safety profile with the REVELATION Helix showing no pulmonary vein pulmonary vein n. A vein that carries oxygenated blood from the lungs to the left atrium of the heart. stenosis before and/or after the procedure. "The REVELATION Helix, coupled with the Cardima NAVIPORT guide catheter, has made the system function effectively for mapping and ablating all four of the pulmonary veins," stated Dr. Lewalter. "The ease of placement and the unique thin linear lesions created with the Helix have combined to produce a very impressive safety profile in those patients we have treated. We have had no pulmonary stenosis pulmonary stenosis n. Narrowing of the opening into the pulmonary artery from the right ventricle. pulmonary stenosis in the clinical trial, which is a significant safety concern being raised by most electrophysiology clinicians doing pulmonary vein ablation. We continue to be impressed with Cardima's microcatheter technology." Additional presentations included: -- Dr. Sung Chun, Associate Director, Cardiac Electrophysiology & Arrhythmia Service of Stanford University, regarding pre-clinical data on both lesion integrity and reduction in tissue damage in the pulmonary veins using the REVELATION Helix. -- Dr. Vivek Reddy, Co-Director, Experimental Electrophysiology Laboratory Cardiac Arrhythmia Service of Massachusetts General Hospital, regarding data on a pre-clinical study involving a pericardial approach to generate linear atrial lesions. -- Dr. Douglas Packer of the Mayo Foundation, Minnesota, on the shift by the electrophysiology community back to linear ablation revisiting both endocardial and epicardial options. "We had another standing-room only event, with approximately 100 physicians and others in attendance at 6:00 a.m. Friday morning as the prominent panel presented clinical data on both the REVELATION Tx and REVELATION Helix," stated Gabriel Vegh, Chief Executive Officer of Cardima. "We are extremely pleased with both the interest concerning our European trial with the REVELATION Helix and the clinical and safety results generated by the trial to date. We also note that the shift in interest back to linear ablation is putting Cardima in the forefront of a technological and clinical groundswell of activity." 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 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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