Cardima Announces U.S. Market Launch of Surgical Ablation System; First Procedure Successfully Performed at Lenox Hill Hospital.Business Editors/Health/Medical Writers FREMONT, Calif.--(BUSINESS WIRE)--Aug. 13, 2003 Marking the U.S. market launch of Cardima(R), Inc.'s (NasdaqSC: CRDM CRDM Control Rod Drive Mechanism CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University) CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) ) Surgical Ablation System, doctors at Lenox Hill Hospital Lenox Hill Hospital, on Manhattan's Upper East Side, is a 652-bed, acute care hospital and a major teaching affiliate of NYU Medical Center. Founded in 1857 as the German Dispensary, today's 10-building Lenox Hill Hospital complex has occupied its present site since 1868 when it in New York City New York City: see New York, city. New York City City (pop., 2000: 8,008,278), southeastern New York, at the mouth of the Hudson River. The largest city in the U.S. , New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of reported great success in the first case application of the system to treat 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). Doctors Didier F. Loulmet, M.D., Chief of the Minimally Invasive Robotic Cardiac Surgery Cardiac surgery is surgery on the heart and/or great vessels performed by a cardiac surgeon. Frequently, it is done to treat complications of ischemic heart disease (for example, coronary artery bypass grafting), correct congenital heart disease, or treat valvular heart disease Program, under the sponsorship of V.A. Subramanian, M.D., Director of Surgery/Senior Cardiac Surgeon, performed the procedure to treat a patient with a long history of chronic AF using Cardima's Surgical Ablation System which ablates cardiac tissue during heart surgery using radio frequency (RF) energy. In the aftermath of the procedure, Dr. Loulmet, who also heads up the Atrial Fibrillation Program for Lenox Hospital, commented, "The unique technology behind the Cardima Ablation System proved to be a critical and powerful tool for this especially difficult case. The ease of use, the power, and the depth of penetration given the small size of the catheter is impressive." "We are pleased that physicians at such an esteemed medical institution as Lenox Hill Hospital have opted to be the first to use our system," said Gabriel Vegh, Chief Executive Officer of Cardima. "This new tool to create long, linear lesions that substantially replicate those of the highly successful surgical Maze procedure maze procedure Cox procedure Heart surgery A procedure used to manage A Fib. See Atrial fibrillation. Cf Corridor procedure. is a ground-breaking addition to the treatment of AF." Cardima's Ablation System received 510(K) approval by 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. ) on February 4, 2003, 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 via the use of radio frequency (RF) energy. This system is expected to be used primarily by cardiac surgeons in the treatment of AF. The physicians performing the procedure described above have been engaged by Cardima as consultants and one or more of them hold equity interests in the Company. The Cardima Ablation System uses commercially available surgical radio frequency generators, a Cardima surgical probe with multi-electrode linear array microcatheter technology similar to the Company's REVELATION(R) Tx, a deflectable guiding sheath similar to the NAVIPORT(R) guiding catheter, and a novel power-channeling device developed by Cardima, the INTELLITEMP(TM), which allows RF energy to be applied to any single, any multiple, or all electrodes on the probe, simultaneously. The surgical ablation probe is also deflectable, allowing surgeons the flexibility to create lesions in various shapes as needed as needed prn. See prn order. to complete the procedure effectively. The Company believes that the Cardima Ablation System can significantly reduce the time required to form lesions and can sense tissue temperature interactively to ensure lesions are uniform, thin and linear. This system is part of Cardima's AF strategy, which is to develop tools to treat patients suffering from irregular heart rhythms. About Cardima Cardima, Inc. has developed the REVELATION(R) Tx, REVELATION(R) T-Flex and REVELATION(R) Helix linear ablation microcatheter systems for the minimally invasive treatment of atrial fibrillation (AF). The REVELATION(R) Helix was developed for the treatment of AF originating in the pulmonary veins of the heart. The REVELATION(R) Tx, REVELATION(R) T-Flex and REVELATION(R) Helix systems 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 for the treatment of AF, to ablate 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 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, 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, the possibility of business disruption or unanticipated expenses due to the Company's recent staffing reduction, 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 market, sell and distribute its products to end users in the United States, in the event FDA approval is obtained, or in other markets. 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, 2002, filed with the Securities and Exchange Commission on March 31, 2003, and the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. for the quarter ended March 31, 2003. 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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