St. Jude Medical Inc. (NYSE:STJ) will showcase its most advanced cardiac care products and present the latest data from clinical studies at Heart Rhythm 2005, the 26th Annual Scientific Sessions of the Heart Rhythm Society (HRS), to be held May 4th - 7th in New Orleans, Louisiana. "Heart Rhythm 2005 brings together the world's leading electrophysiologists and cardiologists to discuss breakthrough cardiac technologies and review the latest clinical research in a lively forum," said Daniel J. Starks, Chairman, President and Chief Executive Officer of St. Jude Medical. "We look forward to presenting our newest innovations, which extend the benefits of our technologies, procedures and clinical studies to many thousands of cardiac patients." Advancements in the Diagnosis and Treatment of AF Atrial fibrillation (AF), the rapid, unsynchronized quivering of the heart's upper chambers - a debilitating condition that affects over six million people worldwide - will be a special focus of Heart Rhythm 2005. St. Jude Medical will profile its most advanced cardiac diagnostic, mapping and visualization technologies for patients suffering from AF or other cardiac rhythm disorders. Among the catheter-based and surgically-based electrophysiology products and technologies to be featured by St. Jude Medical at Heart Rhythm 2005 are the following: -- The Agilis(TM) steerable introducer, which offers outstanding agility and stability to help create precise cardiac ablation lesions. It also offers a steering mechanism to allow small micro-movements with an ablation catheter, along with atraumatic and radiopaque tip markers designed to facilitate safe movement within the atria. -- The EnSite(R) system, which aids navigation of diagnostic and therapeutic catheters used in ablation and other electrophysiology catheterization procedures. -- The Epicor(TM) cardiac ablation system, designed to create cardiac ablation lesions through an off-pump, epicardial approach using High Intensity Focused Ultrasound (HIFU) energy for focused, precise lesions with a less-invasive surgical approach. -- The Inquiry(TM) Optima(TM) diagnostic catheter, which is designed for fast, stable positioning with true 180-degree deflection. It also offers cost-savings by reducing the variety of catheters clinicians need to stock, since the multi-deflectable shaft and variable loop radius diameter make it adaptable to different patient anatomies. -- The Cool Path(TM) steerable irrigated ablation catheter (released in certain markets outside the U.S.), which uses a six port irrigated tip design to help keep catheter tip temperature in the desired range during radiofrequency ablation. Other St. Jude Medical Cardiac Rhythm Management technologies on display at this year's meeting are designed to help manage arrhythmias associated with atrial fibrillation and heart failure, common comorbidities of traditional bradycardia arrhythmias and ventricular tachycardia arrhythmias. These include: -- The QuickSite(R) 1056T bipolar left-heart pacing lead, approved for implantation with St. Jude Medical cardiac resynchronization therapy (CRT) pacing systems; -- The U.S. activation of V-V (ventricle to ventricle) timing in the Epic(TM) HF and Atlas(R)+ HF families of CRT-Ds, which helps physicians optimize individual patient care by adjusting the delay between ventricular outputs and choosing which chamber is paced first; and -- The Frontier(TM) II system, now approved for cardiac resynchronization therapy to reduce the symptoms of moderate to severe heart failure (NYHA Class III or IV and EF less than or equal to 35% and prolonged QRS), and the only device family approved by the U.S. Food and Drug Administration (FDA) for treating patients (NYHA Class II or III) who have undergone an AV nodal ablation for chronic atrial fibrillation. These technologies will complement our offering of new products for the traditional bradycardia and tachyarrhythmia management market segments, including: -- The IsoFlex(R) P bipolar pacing lead, which provides a small diameter, polyurethane insulated lead in both ventricular straight and atrial "J" shapes, designed to promote ease of implant, higher pacing impedances and improved device longevity; -- The Riata(R) i high-voltage lead family, the world's thinnest integrated bipolar implantable cardioverter defibrillator (ICD) lead product, designed to offer physicians even greater flexibility for managing patients with high defibrillation thresholds; -- The Housecall Plus(TM) remote patient monitoring system, allowing physicians to remotely interrogate ICD devices as part of patient follow-up care; and -- The PSA (pacing system analyzer) Wand, which integrates testing, programming and interrogation of implantable cardiac devices into one easy-to-use system without the need for separate analyzer hardware. New Cardiac Surgery Technologies Also on Display St. Jude Medical will also showcase its broad portfolio of mechanical and tissue heart valves, repair products, and other cardiac surgery technologies, including: -- The new SJM(R) Masters HP(TM) Valved Graft with Gelweave Valsalva(TM) technology, which offers surgeons a premium quality composite valve graft combining the exceptional hemodynamics of the St. Jude Medical Masters HP(TM) valve with the implantability advantages of Vascutek's Gelweave Valsalva(TM) Graft (designed to mimic the anatomy of natural sinuses). -- The SJM(TM) Rigid Saddle Ring, to be market launched later this year, which is the first annuloplasty ring available with a complete natural saddle shape, intended to mimic the anatomy of a healthy human mitral annulus. The ring is designed to reduce stress on the chords and leaflets for a more durable repair, while its unique sewing cuff allows for easier suturing. Important Clinical Findings Made Possible by St. Jude Medical Sponsored Research Physicians attending Heart Rhythm 2005 will also be able to hear updated findings from two St. Jude Medical sponsored clinical studies: -- V-V Timing Optimization phase of the RHYTHM (Resynchronization HemodYnamic Treatment for Heart Failure Management) ICD clinical study, which served as the basis for adding V-V timing to St. Jude Medical CRT-Ds; and -- BREATHE (Base Rest Rate Elevation for Apnea Therapy), a clinical study which assesses the impact of an increased pacing rate in pacemaker patients with sleep apnea. Any statements made regarding St. Jude Medical's anticipated future product launches, regulatory approvals, 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, 2004 (see pages 11-16). Actual results may differ materially from anticipated results. St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value.
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