Cardima Launches the Revelation Microcatheter to Treat Atrial Fibrillation at European College of Cardiology.FREMONT, Calif.--(BW HealthWire)--Aug. 21, 1998-- Revelation Microcatheter Is the Only Device Approved 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. Cardima Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CRDM CRDM Control Rod Drive Mechanism CRDM Centre for Rapid Design and Manufacture (Buckinghamshire Chilterns University) CRDM Cumann Rince Dea Mheasa (Irish dancing organisation) ) today announced the formal launch of its Revelation(TM) microcatheter, which recently received CE Mark in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community , at the European College of Cardiology meeting in Vienna, Austria. Atrial Fibrillation (AF) affects approximately 2 million people in the EU and is one of the largest unmet clinical needs in cardiovascular medicine. CE Mark approval allows Cardima to market Revelation through its direct sales force in Germany and France and its network of European distributors. The Revelation microcatheter system has been validated and approved by the EU regulatory body through TUV (Technischer Überwachungs-Verein) Literally "Technical Watch-Over Association." A German certifying body involved with product safety for the European community. Essen, Germany. The Cardima Revelation is the only catheter currently available in the EU approved for both the diagnosis and treatment of AF. The Revelation was approved in Europe in the 1996 and in U.S. in the fall of 1997 for diagnostic use only and this approval extends its use in Europe to allow treatment (radiofrequency ablation Radiofrequency ablation (RFA) A technique for removing a tumor by heating it with a radiofrequency current passed through a needle electrode. Mentioned in: Liver Cancer, Prenatal Surgery ) as well. The feasibility trial to treat AF in the U.S., which has thus far produced similarly excellent results, is almost complete and the company plans to begin a pivotal trial in the U.S. this fall. "The launch of Cardima's Revelation microcatheter is extremely significant for AF patients in Europe," said Phillip Radlick, Ph.D., president and chief executive officer of Cardima. "We have demonstrated the ability of Cardima's Revelation microcatheter to safely and successfully diagnose and treat atrial fibrillation at five centers throughout Europe. "The 90% plus success rate in our clinical trial is remarkable and patients who suffer from AF finally have an alternative to drugs and open-heart surgery open-heart surgery Any surgical procedure opening the heart and exposing one or more of its chambers, most often to repair valve disease or correct congenital heart malformations (see congenital heart disease). that is minimally invasive and curative curative /cur·a·tive/ (kur´ah-tiv) tending to overcome disease and promote recovery. cu·ra·tive adj. 1. Serving or tending to cure. 2. . We are in the process of giving advanced training to the appropriate physicians, in addition to those physicians already trained during the clinical trial. "Patients can learn more about AF and Cardima on the Company's website at www.cardima.com." 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, without limitations, those set forth in the Company's Registration Statement on Form S-1 and periodic reports filed with the Securities and Exchange Commission, and the Company's ability to conduct successful clinical trials, obtain timely regulatory approvals and gain acceptance from the marketplace for its products.
CONTACT: Cardima, Inc.
Ron Bourquin, 510/354-0162
www.cardima.com
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