Cardiac Pathways Announces First Human Use of Proprietary Tracking System Technology.SUNNYVALE, Calif.--(BW HealthWire)--Nov. 8, 1999-- Cardiac Pathways Corporation (Nasdaq:CPWY) today announced that it has successfully completed first human uses of its Tracking Systems for real-time, non-fluoroscopic imaging of cardiac eletrophysiology catheters. The proprietary system, developed by the Company, encompasses diagnostic catheter products and a computer-based system for recording cardiac electrograms. The system is designed to assist physicians in accurately manipulating catheters within the heart during procedures -- without the aid of fluoroscopy fluoroscopy /flu·o·ros·co·py/ (fldbobr-ros´kah-pe) examination by means of the fluoroscope. fluo·ros·co·py n. Examination by means of a fluoroscope. Also called radioscopy. . The catheters contain ultrasound transducers that are used to precisely triangulate See triangulation. , in real-time, the positions of the catheters within the heart during the diagnostic procedure. The supporting computer system combines the utrasonic signals with 3D graphics to display real-time catheter position and track catheter movement, while recording the associated intracardiac intracardiac /in·tra·car·di·ac/ (-kahr´de-ak) within the heart. in·tra·car·di·ac adj. Within the heart. intracardiac within the heart. electrical signals. The Tracking System was used in four patients under the direction of Dr. Martin Schalij and his staff at Leiden University Medical Center The Leiden University Medical Center (Dutch: Leids Universitair Medisch Centrum) or LUMC, is the university hospital affiliated with Leiden University, of which it forms the medical faculty. In Leiden, The Netherlands. Two patients, both over 80 years old, were treated for 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. . Two patients, both over 70 years old, were treated for monomorphic monomorphic /mono·mor·phic/ (-mor´fik) existing in only one form; maintaining the same form throughout all developmental stages. mon·o·mor·phic or mon·o·mor·phous adj. 1. 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. . "The system is really, really wonderful. It's a great way to go back to where you were with the catheter before," noted Dr. Schalig, adding "it really make life so much easier." "We believe this early clinical feedback shows the Tracking System's promise as a technology platform that could revolutionized the way physicians manipulate catheters while reducing the use of x-ray fluoroscopy. Although preliminary, the Cardiac Pathways team is very pleased with these results. Cardiac Pathways believes the Tracking System is going to take many clinicians by surprise. "We believe its ability to document exact locations of multiple catheters during an electrophysiology procedure will be an improvement in the tools available to physicians relative to current offerings in the growing field of 3D Tracking," stated Thomas M. Prescott, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "We are committed to the launch of an integrated system, which will allow for rapid mapping, navigation, and closed system cooled ablation for treatment of complex arrhythmias." Prescott added "Cardiac Pathways is also evaluating multiple applications outside of eletrophysiology for this proprietary technology with various potential partners to leverage out intellectual property." The Tracking System technology has been integrated with the Cardiac Pathways's Chilli(R) Cooled Ablation catheter for 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. treatment of arrhythmias using radio frequency (RF) energy. In September, 1999, the company submitted and application to the 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. ) for approval of the Chilli catheter with integrated Tracking technology. The Tracking System's diagnostic catheters and computer system were submitted for clearance to the FDA in August 1999. To date, the FDA has not acted on either of these applications. This system will permit real-time monitoring of Chilli catheter position during ablation therapy ablation therapy See Ablation–cardiology. , with precise repositioning of the catheter at any time during the procedure to verify prior ablation sites, recording sites, and/or anatomical landmarks, as well as to enhance the efficiency of the therapeutic procedure. Cardiac Pathways develops, manufactures and markets minimally invasive systems to diagnose and treat cardiac tachyarrhythmais (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 heart rhythm disturbances. Statements included in this release that are not historical or current are "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 and are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated. These forward-looking statements and uncertainties include (i) the range of clinical utility for the Tracking System, (ii) the potential reduction in procedure times and, (iii) the potential for reduced x-ray exposure from fluoroscopy. The risks and uncertainties which could cause actual results to differ materially from those anticipated in these forward-looking statements include, but are not limited to the company's ability to complete the development of the Tracking System, market acceptance of the company's products, the company's ability to successfully obtain regulatory clearance or approvals to market its products, the ability of the company to cost effectively manufacture and distribute products in commercial quantities, whether the Tracking System will be approved by the FDA or commercially adopted by physicians, and the company's ability to effectively compete in the field of electrophysiology against its competitors, many of which have substantially greater financial and other resources. |
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