Cardima's Research Collaborators Present Data on Current Non-Pharmacological Treatment of Atrial Fibrillation with the use of the REVELATION Helix and the INTELLITEMP; New Technology Cut Mean Ablation Time in Half.FREMONT, Calif. -- Please replace the release with the following corrected version due to multiple revisions. The corrected release reads: CARDIMA'S RESEARCH COLLABORATORS PRESENT DATA ON CURRENT NON- PHARMACOLOGICAL 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. WITH THE USE OF THE REVELATION HELIX AND THE INTELLITEMP; NEW TECHNOLOGY CUT MEAN ABLATION TIME IN HALF Cardima, Inc. (Other OTC OTC See: Over-the-counter. OTC See over-the-counter market (OTC). : CRDM CRDM Control Rod Drive Mechanism CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University) CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) ) announced today that a presentation by Dr. Naser Elameri et al. entitled "Novel Linear Ablation Method for Rapid Isolation of Pulmonary Veins," will be presented on Monday, July 18, 2005 at the 12th World Congress on Heart Disease on Vancouver, B.C., Canada during the "Arrhythmias and Electrophysiology" session chaired by C. Thomas Peter, Los Angeles, CA, USA, and M.A. Wood, Richmond, VA, USA. The study reports on current non -pharmacological treatment of atrial fibrillation (AF) centering on pulmonary vein isolation (PVI See Present Value Index. ) with the use of REVELATION Helix and compares the effectiveness of using the INTELLITEMP to apply radiofrequency energy with an older model of a switch box. PVI was attempted in 83 veins in 30 patients, resulting in zero occurrences of important complications, an 84% primary success rate of PVI with the use of old switch box and a 100% primary success rate with the use of the INTELLITEMP. Mean time of ablation was reduced from 41.5 to 19.9 minutes. "Although the study population using this catheter is relatively small in comparison to patients who had PVI, we are encouraged with the reported primary success rate and the significant improvements in safety and outcomes associated with using the INTELLITEMP," said Gabriel Vegh, Cardima's Chairman 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. . "Further, the reduction of procedure time is a significant advancement, given both the increased risks associated with lengthy procedures and the increased costs to the healthcare providers." About Cardima Cardima, Inc. has developed the REVELATION 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 Tx, REVELATION T-Flex and REVELATION Helix systems and the INTELLITEMP have received CE Mark approval in Europe. The Company has also developed and obtained approval for in the USA a Surgical Ablation System, which targets market application by cardiac surgeons to ablate ab·late v. To remove or destroy the function of. ablate to remove, especially by cutting. ablate verb To remove; excise cardiac tissue during heart surgery using radio frequency (RF) energy. 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 expressed in or implied by such forward-looking statements. Potential risks and uncertainties include the uncertainties associated with the prospects for 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 our premarket approval premarket approval Medical devices A scientific and regulatory review by the FDA to ensure the safety and effectiveness of a Class III device, before its approval for marketing. See Advisory panel, Medical device. application for the REVELATION Tx, including the ramifications ramifications npl → Auswirkungen pl of our recent meeting with the FDA, the prospect for any future clinical trials or regulatory activities, the Company's ability to obtain funding under the Agility loan facility, the risks associated with the Agility loan facility's restrictive covenants Restrictive covenants Provisions that place constraints on the operations of borrowers, such as restrictions on working capital, fixed assets, future borrowing, and payment of dividends. , security interest, fee provisions and other terms and conditions, the risk that the Company will not be able to raise additional capital in the immediate term as needed as needed prn. See prn order. to continue operations and the risk that we will be unable to secure a strategic transaction involving the Surgical Ablation System. Additional risks and uncertainties are set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2004, the Company's Quarterly Report on Form 10-Q for the first quarter ended March 31, 2005, and in the Company's subsequent SEC filings. 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 or changes in the Company's plans or expectations. |
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