St. Jude Medical Announces FDA Approval and First Implant of the Identity ADx DR Pacemakers.Business Editors/Health/Medical Writers ST. PAUL, Minn.--(BUSINESS WIRE)--April 1, 2003 St. Jude Medical St. Jude Medical, Inc. NYSE: STJ is a $2.9 billion global cardiovascular device company, with headquarters in St. Paul, Minnesota, United States. The company sells products in more than 100 countries and has over 20 operations and manufacturing facilities worldwide. , Inc. (NYSE NYSE See: New York Stock Exchange :STJ STJ Superior Tribunal de Justica (Brazil) STJ Supremo Tribunal de Justiça (Portugal) STJ Superconducting Tunnel Junction STJ San Giljan (postal locality, Malta) ) announced today it has received 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. ) approval to market release the Identity(R) ADx DR and Identity(R) ADx XL DR pacemakers. U.S. launch of these Identity(R) ADx DR models, the world's most advanced pacemakers, is planned for May 2003. Dr. Derek Rodrigues, M.D., F.A.C.C., performed the first Identity(R) ADx pacemaker implant on March 27, 2003 at Overlake Hospital Medical Center in Bellevue, Washington. Dr. Rodrigues implanted an Identity(R) ADx DR Model 5380 device in a 64-year-old female patient who presented with sick sinus syndrome Sick Sinus Syndrome Definition Sick sinus syndrome is a disorder of the sinus node of the heart, which regulates heartbeat. With sick sinus syndrome, the sinus node fails to signal properly, resulting in changes in the heart rate. and a history of premature atrial contractions premature atrial contraction n. Abbr. PAC An ectopic heartbeat that originates in the atria and precedes a typical atrial contraction. . The patient is doing well and the device is functioning as intended. "The Identity ADx DR will help improve the management of patients with 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. tachyarrhythmias," said Dr. Rodrigues. "With the Identity ADx, St. Jude Medical has a dual chamber pacemaker that anticipates almost all of the pacing and diagnostic requirements of our patients. The AutoCapture feature improves energy efficiency and extends the longevity of devices. This is the only pacemaker to provide advanced AT/AF diagnostics with AF Suppression therapy on an excellent proven platform." The St. Jude Medical Identity(R) ADx pacemakers are the first models in the Company's Team ADx product family. These devices incorporate unique AT/AF discrimination and diagnostic features, building upon innovations in previous St. Jude Medical pacemakers including the AF Suppression(TM) algorithm and the Beat-by-Beat(TM) AutoCapture(TM) Pacing System. St. Jude Medical plans to launch additional models of Team ADx devices in May 2003. The Integrity(R) ADx and Verity(TM) ADx pacemakers will follow the Identity(R) ADx in the next several months, offering physicians more choices in feature sets and header configurations. "The Identity ADx pacemakers are designed to offer an even more advanced diagnostic feature set to physicians," commented Michael J. Coyle, President of St. Jude Medical's Cardiac Rhythm Management Cardiac rhythm management is a field of treatment in cardiology. The purpose is managing cardiac rhythm disorders. Usually it involves artificial pacemakers and/or implantable cardioverter-defibrillator therapy as well as antiarrhythmia drugs. business. "With improved AT/AF diagnostic capabilities, these initial products in the ADx family further enhance the tools available to the clinician for the management of drug- resistant atrial tachyarrhythmias in their bradycardia bradycardia: see arrhythmia. patients. Our upcoming release of all pacemakers in the ADx family will be accompanied by enhancements to our programmer software to make device follow-up faster and easier than ever before." Any statements made regarding St. Jude Medical's anticipated future product launches, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2002 (see pages 6-8). Actual results may differ materially from anticipated results. St. Jude Medical, Inc. (http://www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value. |
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