Cardima Surgical Ablation System Presented at 'Controversies in Adult Cardiac Surgery III' Educational Program Santa Monica, CA.Business Editors/Health/Medical Writers FREMONT, Calif.--(BUSINESS WIRE)--Oct. 6, 2003 Lenox Hill Hospital's head of AF Surgical Program presents early results using Cardima's Surgical Ablation System Following the recent U.S. market introduction 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, Didier F. Loulmet, M.D., Chief of the Minimally Invasive Robotic Cardiac Surgery Program 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. , provided the first case reports on four cases using the Cardima Surgical Ablation 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). Dr. Loulmet presented his cases at "Controversies in Adult Cardiac Surgery III", a 2-day educational program sponsored by Cedars-Sinai Heart Center, in Santa Monica, California For other uses, see Santa Monica (disambiguation). Santa Monica is a coastal city in western Los Angeles County, California, USA. Situated on Santa Monica Bay of the Pacific Ocean, it is surrounded by the City of Los Angeles — Pacific Palisades and Brentwood on the north, . Dr. Loulmet, who also heads the Atrial Fibrillation Program for Lenox Hill Hospital, delivered his presentation, entitled "A Novel Surgical Approach to the Treatment of Atrial Fibrillation," as part of the "Surgery for Arial Fibrillation" session. According to Dr. Loulmet, all four cases he has completed so far have had a consistent pattern of response. "We have been impressed with the visual consistency and clarity of the thin lesion pattern created and with the remarkable consistency of the clinical outcome of those patients treated. Although our experience base is small, Cardima's system has provided us with consistent results on a category of patients that are very difficult to treat. These patients were in chronic AF ranging from 8 to 15 years. All four patients remain in normal sinus rhythm sinus rhythm n. A normal cardiac rhythm proceeding from the sinoatrial node. without the aid of drug therapy." Dr. Loulmet continued, "Compared with what we have seen to date, this system is very encouraging." In February 2003, Cardima, Inc. received 510(k) clearance from 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. to market its Surgical Ablation System in the United States. The Cardima Ablation System was first utilized by cardiac surgeons at 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 City's Lenox Hill Hospital to repair damaged heart tissue in patients with a long history of chronic AF in conjunction with valve disease. The system is composed of a surgical ablation probe, an energy management device, and a unique delivery system. These collectively enable the surgeon to create curvilinear curvilinear a line appearing as a curve; nonlinear. curvilinear regression see curvilinear regression. scars in the heart muscle or walls. This scar tissue scar tissue n. Dense, fibrous connective tissue that forms over a healed wound or cut. blocks the signals, which cause the heart to go into atrial fibrillation. Cardima believes that the system represents a significant possibility for surgeons to safely and effectively treat atrial fibrillation. The physician performing the procedures described above has been engaged by Cardima as a consultant and may hold direct or indirect equity interests in Cardima. About Cardima Cardima, Inc. has developed the REVELATION Tx, REVELATION T-Flex and REVELATION Helix linear ablation microcatheter systems 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 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 are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those expressed in or contemplated by such forward-looking statements. Potential risks and uncertainties include difficulties inherent in predicting the safety and effectiveness of the Surgical Ablation System based on the small number of cases to date, the Company's ability to raise additional capital, whether 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. application will be approved by the U.S. FDA, and whether the Company will be able to conduct successful clinical trials, obtain and maintain regulatory approvals, gain acceptance from the marketplace for its products, 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 Reports on Form 10-Q Form 10-Q See 10-Q. , as amended, for the quarters ended March 31 and June 30, 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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