St. Jude Medical Announces the European Market Launch of the QuickSite 1056T Bipolar CRT Lead; World's First Bipolar CRT Lead with Composite Body and ''S'' Tip.ST. PAUL, Minn. -- 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 the European market launch of the QuickSite(R) 1056T bipolar left-heart pacing lead, the world's first cardiac resynchronization therapy (CRT (1) (C RunTime) See runtime library. (2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons. ) lead to combine bipolar pacing capability with a composite body for superior handling and a unique S-shaped distal tip for outstanding stability. The lead represents the next advance in the QuickSite(R) family of left-heart leads. "We are very pleased to be able to offer our customers the bipolar version bipolar version n. See bimanual version. of our highly successful QuickSite left-ventricular lead for cardiac resynchronization therapy," said Joseph H. McCullough, President of St. Jude Medical's International Division. "The bipolar QuickSite 1056T lead builds on the outstanding design features of the QuickSite 1056K unipolar lead, which clinicians have appreciated for its excellent stability and handling characteristics that allow for improved placements in challenging coronary sinus anatomy." Specifically designed for placement in the coronary sinus, the St. Jude Medical QuickSite(R) 1056T bipolar lead enables left-ventricular pacing in cardiac resynchronization therapy applications. At 5.5 French, the lead body is as small in diameter as the previously available QuickSite(R) 1056K unipolar lead. "Real therapy optimization benefits are made possible by combining the QuickSite 1056T bipolar lead with the V-V timing feature included in our CRT devices," added 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. Division. "Since we can't predict which patients will respond to simultaneous pacing and which will not, programmable V-V timing allows physicians to adjust the delay between contraction of the left and right ventricles and choose which chamber is paced first. This enhanced device functionality provides clinicians with additional therapy options based on individual patient needs." The St. Jude Medical QuickSite(R) 1056T bipolar CRT lead offers innovations and advances that include: --A polyurethane body that transitions to a distal silicone tip section designed for optimal pushability, torque transfer and tip flexibility; --A steerable, S-shaped distal tip designed to improve maneuverability and anchoring of the lead at distal as well as more proximal locations within the coronary sinus; --A choice of either a ball-tipped guiding stylet stylet /sty·let/ (sti´lit) 1. a wire run through a catheter or cannula to render it stiff or to remove debris from its lumen. 2. a slender probe. sty·let n. 1. or a guidewire during the same implant for maximum flexibility in lead placement; --A radiopaque ra·di·o·paque adj. Relatively impenetrable by x-rays or other forms of radiation. radiopaque (rā´dēōpāk´), adj suture sleeve that enhances visibility on 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. without blocking visibility of the underlying coils; and --Grooved, circumferential tip electrode designed to enhance stability and thresholds. The QuickSite(R) 1056T lead is designed to work with the St. Jude Medical Epic(TM) HF CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators , the world's smallest high-voltage cardiac resynchronization device, and the Atlas(R)+ HF CRT-D, the world's highest energy output cardiac resynchronization therapy device, to treat heart failure. It will also work with the recently released Frontier(TM) II biventricular cardiac stimulation device. The lead has been submitted to 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. ) for approval in the United States. Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood to the body. The worldwide economic burden of heart failure is estimated at $80 billion per year. 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, 2003 (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 unmatched clinical performance and demonstrated economic value. |
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