Cardima Submits Second Module in PMA Filing for Atrial Fibrillation Treatment.Business Editors & Health/Medical Writers FREMONT, Calif.--(BW HealthWire)--May 15, 2001 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 microcatheter system 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), today announced that it submitted to the 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. ) the second module of the company's 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. (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 supporting the safety and effectiveness of the REVELATION Tx microcatheter system for the treatment of AF. The company announced the filing of the first module along with FDA acceptance of the "PMA Shell" on April 3, 2001. There are currently five modules comprising this PMA. "The regulatory process for the REVELATION series of ablation microcatheters is progressing on schedule. We expect that the third module will be completed shortly, getting us one step closer to reaching our goal of developing a minimally invasive treatment for people suffering with atrial fibrillation," commented Gabriel Vegh, chief executive officer of Cardima. "Importantly, our REVELATION Tx system holds the potential to cure AF, not merely treat the symptoms." The company's 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 pivotal clinical study of paroxysmal paroxysmal (per´  ksiz´ml),adj recurring in paroxysms. atrial fibrillation began in October 2000, and will supplement the Phase II data with up to an additional 80 patients being treated at up to 20 U.S. centers. Patients enrolled in this Phase III trial must have failed two levels of prior drug therapy, and will be monitored for six months after their treatment with the REVELATION Tx system. Cardima Inc. developed the REVELATION Tx system for the treatment of AF, which the company estimates is a potential $6 billion market that is poorly served by current treatment alternatives. AF afflicts an estimated 2.2 million people in the United States and approximately 4.5 million worldwide. The REVELATION Tx system is a minimally invasive, single-use, microcatheter-based product for potentially curing AF, and is believed to be 2-3 years ahead of other development-stage ablation therapies in the approval process. Phase I and II data with the REVELATION Tx system demonstrated safety and promising efficacy; enrollment in a Phase III study is underway, and is expected to be completed in the second half of 2001. Except for the historical information contained herein, the matters discussed in this news 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 Dec. 31, 2000, and Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2001, filed with the Securities and Exchange Commission on March 22 and May 14, 2001, respectively. 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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