Cardima, Inc. Announces FDA Clearance of Naviport Deflectable Tip, Hollow Lumen Guiding Catheter; A New Generation of Guiding Catheters.FREMONT, Calif.--(BW HealthWire)--Aug. 5, 1999-- Cardima, 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) ) today announced that it has received 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. (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. ) 510(k) clearance to begin marketing its proprietary Naviport(tm) deflectable tip guiding catheter. The patented Naviport is the only deflectable tip guiding catheter with an open lumen or tube, designed to access the chambers and/or the coronary vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur) 1. circulatory system. 2. any part of the circulatory system. vas·cu·la·ture n. of the heart. Guiding catheters are used as conduits by physicians to direct catheters to specific sites in the body. The Naviport shortens electrophysiology procedure times through faster catheter placement by its unique ability to steer to a particular location. The Naviport also received 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 CE mark approval in March of 1999. "The Naviport is the latest addition to Cardima's family of guiding catheters that include the Venaport(R) line of guiding catheters and Vueport(tm) line of balloon occlusion guiding catheters," said Phillip Radlick, Ph.D., President and Chief Executive Officer of Cardima. "The Naviport is a key component of Cardima's therapeutic ablation system currently in clinical trials in the United States for 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). It has the potential for broad applications to deliver a wide range of small, high technology, non-steerable catheters to the body." Features of the Naviport include an ergonomic control knob offering physicians precise, controlled steering with appropriate curvature while maintaining the selected curve shape, and an open lumen or tube with a deflectable tip that provides easy delivery, placement and support of catheters in the desired location. The Naviport will be marketed in various diameters and curve sizes and is available through Cardima's direct salesforce in the United States and web site at www.cardima.com. Cardima, Inc. designs, develops, manufactures and markets minimally invasive, single-use microcatheter-based systems for the dual purpose of finding and treating the two most common forms of cardiac arrhythmias: atrial fibrillation, a condition of the heart characterized by the irregular and very rapid beating of the heart's atrial atrial /atri·al/ (a´tre-al) pertaining to an atrium. a·tri·al adj. Of or relating to an atrium. Atrial Having to do with the upper chambers of the heart. chambers, and ventricular tachycardia Ventricular Tachycardia Definition Ventricular tachycardia (V-tach) is a rapid heart beat that originates in one of the lower chambers (the ventricles) of the heart. , a life-threatening condition in which heartbeats are improperly initiated from within the ventricular walls, bypassing the heart's normal conduction system conduction system systema conducens cordis Anatomy A network of specialized nerve fibers innervated by both the sympathetic–SNS and parasympathetic nervous systems–PNS; PNS stimulation, eg, ↑ vagal stimulation, ↓ sinus node automaticity . Cardima is the only company developing unique microcatheter systems to be used in both diagnosing and treating AF and VT. For further information about atrial fibrillation and ventricular tachycardia, visit Cardima'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 limitation, those set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 1998 as amended March 23, 1999 and subsequent periodic reports filed with the Securities and Exchange Commission, and the Company's ability to complete successful clinical trials, obtain timely regulatory approvals and gain acceptance from the marketplace for its products. |
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