Cardiac Pathways Files 510k Application With the FDA For Its Mercator Atrial High Density Array Catheter For Diagnosing Irregular Heart Rhythms.SUNNYVALE, Calif.--(BW HealthWire)--July 20, 1998--Cardiac Pathways Corp. (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 it has filed a 510(k) application with 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. ) for marketing clearance for its Mercator(TM) 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. High Density Array Catheter. The Mercator Catheter Mercator catheter Cardiology A high-density array catheter used in the right atrium to map and diagnosis complex arrhythmias and assess the effectiveness of ablation treatment. See Ablation therapy. is intended to be used for diagnosing and mapping atrial arrhythmias, including atrial flutter atrial flutter n. Rapid regular atrial contractions occurring usually at rates between 250 and 400 per minute and often producing saw-tooth waves in an electrocardiogram. Also called auricular flutter. 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. , common heart rhythm disturbances that sometimes cause blood clots that can lead to strokes. The Mercator Atrial High Density Array Catheter is a high density, 64-electrode basket with eight arms designed for rapidly assessing arrhythmias within the right atrium and determining the effectiveness of ablation procedures used to treat the arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of . The Mercator Atrial High Density Array Catheter is used in conjunction with the Cardiac Pathways' Model 8100/8300 Arrhythmia Mapping System to capture and display information about the conduction activity in the right atrium, allowing the physician to determine the source of the arrhythmia as well as the effectiveness of treatment. "Cardiac Pathways has taken an integrated design approach to its Mercator family of high resolution mapping baskets and the Arrhythmia Mapping System, offering efficacious electrophysiology tools for diagnosing arrhythmias, such as atrial flutter and atrial fibrillation," states 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. . "This technology may potentially lead to minimally invasive treatment for patients with these serious rhythm disturbances." Cardiac Pathways 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 improved diagnosis and treatment of ventricular tachycardia and atrial fibrillation, two of the most serious and prevalent types of heart rhythm disturbances. 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 progress of the company's actions relating to regulatory matters, the costs and timing of expansion of product development, manufacturing, marketing and sales activities, the extent to which the company's products gain market acceptance, and competitive developments.
CONTACT: Cardiac Pathways Corporation
David W. Gryska, 408/737-0505
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