Cardiac Pathways Receives FDA Clearance for Its Arrhythmia Mapping System.SUNNYVALE, Calif.--(BW HealthWire)--Aug. 13, 1997--Cardiac Pathways Corporation (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 :CPWY) announced today that 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. ) has granted the Company approval of its 510(k) application to commercially release its Arrhythmia Mapping arrhythmia mapping Cardiology The use of hardware and software to ID the source of tachyarrhythmias; radiofrequency ablation is then directed to the specific arrhythmogenic site for potentially curative treatment. See Tachycardia. System for use in the diagnosis of patients with abnormally rapid heart rhythms, or tachyarrthymias. The Company plans to begin shipping the Arrhythmia Mapping System in the U.S. market in August 1997. The Arrhythmia Mapping System is used to diagnose, or map, electrical activity within the heart, identifying the source of the tachyarrthymthia. The system consists of custom hardware and software to acquire and display data from over 100 input channels comprising signals that detail the heart's electrical function. The custom software function, running on a Sun Microsystems Workstation, represents the state of the art in cardiac electrophysiology data display techniques. The information it provides is critical for directing curative 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 to the site responsible for the rhythm disorder. Another key data display feature of the system, known as isochronal i·soch·ro·nal or i·soch·ro·nous adj. 1. Equal in duration. 2. Characterized by or occurring at equal intervals of time. mapping, is currently being evaluated in multicenter clinical trials of the Company's Mercator, a high-resolution 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. and ventricular mapping basket. The mapping basket is expected to be available in the U.S. by the end of 1998 following FDA clearance. Isochronal mapping presents the physician with an easy-to-read color map that indicates the appropriate site for ablation. The Cardiac Pathways Arrhythmia Mapping System is the culmination of a multi-year system design effort encompassing high resolution, multi-electrode mapping basket catheter development, as well as the custom hardware and software development of the mapping system. President and Chief Executive Officer, William Starling starling, any of a group of originally Old World birds that have become distributed worldwide. Starlings were brought to New York in 1890; since then the common starling (Sturnus vulgaris) has spread throughout North America. states, "By taking a fully integrated system design approach to both the Arrhythmia Mapping System and Mercator family of high resolution mapping baskets, Cardiac Pathways has uniquely positioned itself at the clinical forefront of complex tachyarrhythmia tachyarrhythmia /tachy·ar·rhyth·mia/ (tak?e-ah-rith´me-ah) any disturbance of the heart rhythm in which the heart rate is abnormally increased. tach·y·ar·rhyth·mi·a n. diagnostics. "When coupled with our Chilli(R) cooled ablation catheter and Model 8004 RF generator, Cardiac Pathways has developed an innovative technology platform by combining the therapeutic and diagnostic components of care for patients suffering from complex tachyarrhythmias." Cardiac Pathways Corporation designs, develops and manufactures minimally invasive systems to diagnose and treat cardiac tachyarrhythmias (abnormally rapid heart rhythms). The Company is developing products designed to provide integrated system solutions for the successful diagnosis and treatment of 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. and 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. , two of the most serious and prevalent types of abnormally rapid heart rhythms. -0- This release contains certain forward-looking statements that involve risks and uncertainties. Actual results could differ materially from those anticipated in these forward looking statements as a result of certain factors, including the Company's success in completing any remaining development of the products discussed, the efficacy and safety of the products in the laboratory, clinical and other testing, the uncertainties relating to FDA and other regulatory approvals, and additional factors. CONTACT: Cardiac Pathways Corporation David W. Gryska, 408/737-0505 |
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