Cardima Receives Non-Approvable Letter from FDA for REVELATION Tx.Business Editors/Health/Medical Writers FREMONT, Calif.--(BUSINESS WIRE)--May 28, 2004 Today, 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) ) received a letter, dated May 21, 2004, from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. , stating that Cardima's pre-market approval application (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 ) for the REVELATION(R) Tx Microcatheter with NavAblator Ablation ablation /ab·la·tion/ (-shun) 1. separation or detachment; extirpation; eradication. 2. removal or destruction, especially by cutting. ab·la·tion n. System indicated for the treatment of drug refractory paroxysmal paroxysmal (per´  ksiz´ml),adj recurring in paroxysms. 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. was not approvable based on the requirements of applicable regulations. The letter stated that although Cardima had provided information on an additional 32 patients in the 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 REVELATION(R) Tx clinical trial in its PMA amendment submitted in January 2004, the concerns identified in the FDA's initial non-approvable letter, dated June 26, 2003, remain unresolved. Among other things, the FDA's letter stated that the 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. believes that the least burdensome approach to demonstrate the safety and effectiveness of REVELATION Tx for the intended indication is to collect additional clinical data using a revised study design. At the FDA's suggestion, Cardima has requested a meeting with the FDA to discuss next steps toward seeking approval. 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 pulmonary vein n. A vein that carries oxygenated blood from the lungs to the left atrium of the heart. 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 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 risk that the Company will not be able to raise additional capital, the risk that the Company's pre-market approval (PMA) application for the REVELATION(R) Tx will not be approved by the FDA particularly in light of the FDA's non-approvable letter received on May 28, 2004, the risk that the Company will be unsuccessful in obtaining or maintaining regulatory approvals for other products, the risk that the approval process for any product will require unanticipated expenses, the limited number of cases employing the Company's products and the limited amount of follow-up information involving these cases, 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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