Cardiac Pathways Submits IDE for Its Nexus 2 Catheter for the Treatment of Atrial Arrhythmias.SUNNYVALE, Calif.--(BW HealthWire)--Oct. 3, 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), a developer of minimally invasive, cost-effective systems for diagnosing and treating abnormally rapid heart rhythms, today announced that it has submitted an Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and supplement to 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 its Nexus 2 Catheter, a device designed to treat 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. . The Nexus 2, a modified version of the Company's Nexus Linear Ablation Catheter, was developed to improve the ability to create linear lesions in the atria Atria The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. , which are needed to effectively treat atrial arrhythmias. The Nexus 2 features an optimized saline interface electrode design and improved handling characteristics to facilitate tissue contact during the treatment of atrial flutter. The new catheter will be evaluated for the treatment of atrial flutter in the right atrium, followed by studies of its use in treating atrial fibrillation, primarily in the left atrium. Atrial flutter is a common rhythm disturbance usually originating from the right atrium, or upper chamber of the heart. It is estimated that 200,000 new cases of atrial flutter occur in the U.S. each year. Atrial flutter is now routinely treated with catheter ablation Catheter Ablation Definition Catheter ablation of an irregular heartbeat involves having a tube (a catheter) inserted into the heart through which electrical energy is sent to either reset the heartbeat or stop the heart from beating so a mechanical , using a slow point-by-point technique to form a linear lesion. The Nexus 2 catheter is designed to rapidly create a linear lesion with a single application. Atrial fibrillation affects two million Americans, often causing blood clots Blood Clots Definition A blood clot is a thickened mass in the blood formed by tiny substances called platelets. Clots form to stop bleeding, such as at the site of cut. leading to stroke. "The Nexus Linear Ablation Catheter has the potential to safely and quickly produce lesions in the atria. Compared to other metal electrode designs intended to create linear lesions, the Nexus should dramatically increase the effectiveness of curative ablation therapy for atrial flutter and atrial fibrillation," said William N. 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. , president and chief executive officer of Cardiac Pathways. Cardiac Pathways designs, develops and manufactures minimally invasive systems to diagnose and treat cardiac tachyarrhythmias (abnormally rapid heart rhythms). The Company is a pioneer and leader in the development of complete, integrated mapping and ablation systems for the 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 clinical trials, 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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