St. Jude Medical Announces Regulatory Approvals and Market Launch of the QuickSite XL Lead.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) ) today announced 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, receipt of European CE Mark clearance and market launch of the QuickSite(R) XL bipolar, left-heart lead to treat heart failure patients. The QuickSite XL lead is used in 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. ) procedures for heart failure patients with average to large size veins. The lead's heightened S-shape is designed to provide stability and allow physicians to successfully position it in bigger veins. "Establishing lead stability is one of the challenges of cardiac resynchronization therapy that the QuickSite XL lead addresses, helping physicians achieve stability more easily and reliably in a broader range of patients," said John Rogers, M.D., of Scripps Clinic in La Jolla, Calif. Cardiac leads are used to connect a CRT device to a patient's heart. The lead senses when the heart is functioning normally and sends that information back to the implanted device. When needed, the lead also delivers a pacing pulse. "The QuickSite XL lead showed excellent tracking and visibility, which allowed me to see precisely where it was going and to secure it at the best position in the heart for resynchronization therapy using its original S-shape curve," added Daniel Gras, M.D., of Nouvelles Cliniques Nantaises in Nantes, France, who was among the first to implant the lead in Europe. The QuickSite XL lead complements two previously approved products in the QuickSite lead family. Studies have shown that QuickSite leads maneuver well through difficult passageways in the heart and remain stable at sites selected by physicians for optimal care, resulting in a high implant success rate and low dislodgement rate. The QuickSite XL bipolar lead bipolar lead n. 1. The electrical connection of two electrodes to a recording instrument and to two different places on the body, such as the chest and a limb. 2. A record obtained from the combined input of the two electrodes. is designed for use with St. Jude Medical's Epic(TM) HF CRT-D CRT-D Cardiac Resynchronization Therapy - Defibrillators (CRT 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 ), the Atlas(R)+ HF CRT-D, and the Frontier(TM) II CRT-P, the world's smallest and longest-lasting CRT pacemaker, to treat heart failure. Heart failure is a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood in the body. About 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. "Our goal is to extend the life-enhancing benefits of cardiac resynchronization therapy to patients who may benefit from a larger lead curve size," said 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. "We're encouraged by the enthusiastic response physicians have voiced about the new QuickSite XL lead." About St. Jude Medical St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation atrial fibrillation Irregular rhythm (arrhythmia) of contraction of the atria (upper heart chambers). The most common major arrhythmia, it may result as a consequence of increased fibrous tissue in the aging heart, of heart disease, or in association with severe infection. , cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., the Company employs approximately 10,000 people worldwide. For more information, please visit www.sjm.com. This news release contains forward-looking statements within the meaning 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 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success. The statements made by the Company are based upon management's current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the Company's control and the risk factors and other cautionary statements described in the Company's filings with the SEC, including the Cautionary Statements described in the Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21).The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance. |
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