Guidant Announces FDA Approval of Next-Generation Implantable Defibrillator; VITALITY AVT Implantable Defibrillator Offers Complete Ventricular and Atrial Therapy Options.Business Editors/Health/Medical Writers INDIANAPOLIS, Ind. & ST. PAUL, Minn.--(BUSINESS WIRE)--April 1, 2003 Guidant Corporation (NYSE NYSE See: New York Stock Exchange :GDT GDT Global Descriptor Table GDT Geographic Data Technology Inc. GDT Gas Discharge Tube (energy, electrotechinical and electronics) GDT Getting Things Done GDT Geometric Dimensioning & Tolerancing GDT Ground Data Terminal ), a world leader in the treatment of cardiac and vascular disease, today announced 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 of its next-generation implantable defibrillator--the VITALITY(TM) AVT AVT avian arginine vasotocin. See vasotocin. (R) implantable cardioverter defibrillator defibrillator, device that delivers an electrical shock to the heart in order to stop certain forms of rapid heart rhythm disturbances (arrhythmias). The shock changes a fibrillation to an organized rhythm or changes a very rapid and ineffective cardiac rhythm to a (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. ) system. This new technology combines complete ventricular and atrial therapies in the world's smallest (30cc) and thinnest (11mm) dual chamber ICD. Full commercial launch of the VITALITY AVT ICD in the United States will occur later this quarter. "The VITALITY AVT is another leading edge product from Guidant," said Fred McCoy, president, 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. , Guidant Corporation. "Our physician customers demand excellent therapeutic and diagnostic performance from our ICD systems. VITALITY AVT provides this exceptional ICD performance in combination with valuable atrial options. VITALITY AVT brings these new advantages without compromise." The VITALITY AVT ICD combines the best of Guidant's cardiac rhythm management solutions. The VITALITY AVT ICD's atrial options include: -- Atrial Rhythm Classification (ARC), a highly sophisticated algorithm specifically designed to distinguish between benign atrial arrhythmias and those that may adversely affect ventricular rate. -- Atrial overdrive pacing, designed as an option to maintain a normal rhythm. -- Ventricular Rate Regulation (VRR VRR Verkehrsverbund Rhein-Ruhr VRR Vertical Refresh Rate (monitors and television VRR Variance Reduction Ratio VRR Voice Recognition Response VRR Virtual Router Redundancy VRR Verification Readiness Review ), an exclusive algorithm designed to stabilize the ventricular rate during an atrial 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 . -- Atrial programming options to convert the heart back to a normal rhythm, either automatically or using the PARTNER(TM) Rhythm Assistant, a handheld device that allows patients to initiate therapy programmed by the physician. Guidant also announced today FDA approval of the VENTAK PRIZM PRIZM Potential Rating Index for Zip Marketers (Claritas, Inc.) PRIZM Primal Zoo Machine (band) (R) AVT(R) implantable cardioverter defibrillator. This offering represents Guidant's latest addition to the PRIZM family of defibrillators. The PRIZM AVT ICD, like the VITALITY AVT ICD, includes advanced therapies and diagnostics to treat arrhythmias--irregular or dangerously fast heart rhythms--that originate in either the upper or lower chambers of the heart. The PRIZM AVT ICD has been available outside the United States since May 2001. The VITALITY AVT ICD builds on Guidant's successful track record of developing advanced cardiac performance solutions. Both The VITALITY AVT and the PRIZM AVT ICDs leverage the proprietary intellectual property Guidant acquired in 1998 through its purchase of InControl, Inc., a technology company that focused on atrial therapies. Guidant Corporation pioneers lifesaving technology, giving an opportunity for better life today to millions of cardiac and vascular patients worldwide. The company, driven by a strong entrepreneurial culture of 11,000 employees, develops, manufactures and markets a broad array of products and services that enable less invasive care for some of life's most threatening medical conditions. For more information visit www.guidant.com. NOTE TO MEDIA: For more information about Guidant, including its products and services, please visit the company's newsroom at www.guidant.com/newsroom. This release includes forward-looking statements concerning the product launch and use of the therapy. The statements are based on assumptions about many important factors, including ordinary production and marketing operations, any regulatory developments, and other factors identified on Exhibit 99.1 to the company's most recent 10-K. Actual results may differ materially. The company does not undertake to update its forward-looking statements. |
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