Cardima Announces Acute Success in Achieving Pulmonary Vein Isolation with 70% Reduction in Ablation Time Due to the Use of the INTELLITEMP.Business Editors/Health/Medical Writers FREMONT, Calif.--(BUSINESS WIRE)--May 25, 2004 During a symposium on new advances in linear ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. for 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. , held on May 20, 2004, Jaswinder S. Gill, M.D., Consultant Cardiologist Cardiologist Doctor who specializes in diagnosing and treating heart diseases. Mentioned in: Electrophysiology Study of the Heart, Lithotripsy cardiologist a physician who specializes in the diagnosis and treatment of heart disease. and Director of Pacing and Electrophysiology, Guy's & St Thomas Hospital, London, England and Senior Lecturer senior lecturer n. Chiefly British A university teacher, especially one ranking next below a reader. , King's College King's College, former name of Columbia Univ. London, reported acute success on achieving pulmonary vein pulmonary vein n. A vein that carries oxygenated blood from the lungs to the left atrium of the heart. (PV) isolation using Cardima's Helix STX STX - Start Of Text 2.5 microcatheter with 16 3mm electrodes and INTELLITEMP(R), Cardima's proprietary radio frequency (RF) energy management system. Cardima, 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) ) sponsored the symposium, which was held in conjunction with the Heart Rhythm Noun 1. heart rhythm - the rhythm of a beating heart cardiac rhythm regular recurrence, rhythm - recurring at regular intervals atrioventricular nodal rhythm, nodal rhythm - the normal cardiac rhythm when the heart is controlled by the Society annual meeting. The presentation compared single electrode ablation with multi-electrode ablation. Dr. Gill found a 70% reduction in ablation time when the electrodes were energized by the INTELLITEMP as compared to his use of a manual switchbox controller. This was the first study demonstrating results of the Cardima Ablation System used as originally intended: multi-electrode mapping and ablation with the same device using the INTELLITEMP to control RF energy delivery. Dr. Gill reported on the treatment of 16 patients using the INTELLITEMP and REVELATION(R) Helix STX 2.5 microcatheter, representing the first clinical series using the REVELATION Helix STX 2.5 with 16 3mm electrodes and INTELLITEMP. All patients suffered with highly symptomatic paroxysmal paroxysmal (per´ adj recurring in paroxysms. atrial fibrillation and were refractory to 3 anti-arrhythmic drugs. The function of the INTELLITEMP was to simultaneously channel RF energy to each individual electrode on the end of the microcatheter, thereby giving Dr. Gill the ability to control the length of each lesion through the selection of one or any combination of up to sixteen electrodes simultaneously. Average power for each of the 16 electrodes required to deliver target temperature was in the 6 to 15 watt range, well below other RF devices. This low functional energy requirement is another indication of the efficiency of the use of RF through our unique "fine wire" electrode technology. Safety of treatment is a concern of medical professionals, especially for those devices which require high energy output in order to achieve target temperature levels. Cardima believes its technology fills an important void in the area of RF energy transfer to effected tissue within optimized safety parameters. Further, it is interesting to note Dr. Gill reported tight average target temperature control across all 16 electrodes, which suggests better control of available energy. Safety, clinical efficacy, and time savings were highlights of the presentation. Gabriel Vegh, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cardima said, "We are pleased and encouraged with the acute success achieved by Dr. Gill in isolating the pulmonary veins with our INTELLITEMP RF ablation system, a promising tool for the effective treatment of atrial fibrillation." The CARDIMA INTELLITEMP, which received CE Mark clearance for EP applications on February 19, 2004, is a radiofrequency (RF) energy management device which is connected between a commercially available RF generator and the Cardima REVELATION series of linear ablation microcatheters. The function of the INTELLITEMP is to discretely channel RF energy to each individual electrode on the end of the microcatheter, thereby giving the medical practitioner the ability to control the length of each individual lesion through the selection of one or any combination of up to sixteen electrodes simultaneously. Further, the INTELLITEMP measures temperatures in such a manner as to ensure optimum control of target temperatures, which add to the safety of the procedure. About Cardima Cardima, Inc. has developed the REVELATION(R) Tx, REVELATION T-Flex and REVELATION Helix linear ablation microcatheters, the NAVIPORT deflectable guiding catheters, and the INTELLITEMP energy management system for the minimally invasive treatment of atrial fibrillation (AF). The REVELATION Helix was developed for the treatment of AF originating in the pulmonary veins of the heart. The REVELATION Tx, REVELATION T-Flex and REVELATION Helix systems and the INTELLITEMP have received CE Mark approval in Europe. The Company has also developed a Surgical Ablation System, which is expected to be used by cardiac surgeons to treat AF by ablating cardiac tissue during heart surgery using radio frequency (RF) energy. In February 2003, the Company announced that it had received 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. 510(k) clearance to market the Surgical Ablation System in the U.S. Except for the historical information contained herein, the matters discussed in this press release, including the Company's belief about the performance and utility of its products, are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by such forward-looking statements. Potential risks and uncertainties include the limited number of cases employing the Company's products and the limited amount follow-up information involving these cases, the risk that the Company will not be able to raise additional capital, whether the Company's 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 for the REVELATION(R) Tx or any other product will be approved by the FDA and whether the approval process will require unanticipated expenses, the possibility of business disruption or unanticipated expenses due to the Company's recent staffing reduction and financing efforts, and whether the Company will be able to conduct successful clinical trials, obtain and maintain regulatory approvals, gain acceptance for its products from the marketplace, secure distribution partners or successfully manufacture, market, sell and distribute its products to end users in the event regulatory approvals are obtained. 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, 2003, and in the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the period ended March 31, 2004. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events or changes in the Company's plans or expectations. |
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