Cardiac Pathways Scheduled for July 21-22, 1998 FDA Panel Review Meeting for Its Chilli Cooled Ablation System.SUNNYVALE, Calif.--(BW HealthWire)--June 24, 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) today announced 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 scheduled the Panel Review meeting with the company for Tuesday, July 21 and Wednesday, July 22, 1998 to discuss its premarketing approval (PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy ) submission filed for the Chilli(R) Cooled Ablation System. The Chilli Cooled Ablation System is designed to treat patients with 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. (VT), a life threatening, rapid heart rhythm that usually originates in the left ventricle -- the main, lower pumping chamber of the heart. Most VT results from coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. and the scarring that follows a heart attack. The majority of VT patients are currently treated with drug therapy and/or implantable defibrillators. Cardiac Pathways believes catheter ablation is a less invasive, more efficacious technique for eliminating the rhythm disturbance at its source. The catheter ablation procedure uses radiofrequency (RF) energy delivered through a catheter to neutralize the heart tissue responsible for the abnormal heart rhythm. The Cardiac Pathways Chilli Cooled Ablatin System may be a new treatment option for approximately 160,000 of the 400,000 people per year in the U.S. who suffer from or are at risk for VT, if FDA marketing approval for the device is received. Designed to provide catheter ablation in cases of VT, the Chilli Cooled Ablation System addresses the need to make deep lesions that can penetrate thick ventricular scar tissue and target ablation sites deep within the heart's wall. The Chilli catheter contains small lumens, or tubes, that deliver cooling saline to the tip of the catheter in order to remove heat that can build up during ablation and limit the effectiveness of the procedure. The system includes a RF generator that contains an integrated fluid pump to circulate the saline liquid through the catheter while delivering RF ablative ablative (ăb`lətĭv') [Lat.,=carrying off], in Latin grammar, the case used in a number of circumstances, particularly with certain prepositions and in locating place or time. The term is also used in the grammar of some languages (e.g. energy to treat the patient's 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 panel review meeting with the FDA is a significant milestone in our efforts to commercialize the Chilli System. We remain encouraged by the FDA's willingness to grant us an expedited review and believe a favorable recommendation by the FDA could result in the U.S. launch of this product in late 1998," 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. , Cardiac Pathways president and chief executive officer. 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 extent to which the Company's products gain market acceptance, and competitive developments.
CONTACT: Cardiac Pathways Corp.
David W. Gryska, 408/737-0505
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