St. Jude Medical Announces Expanded European CE Mark to Include Therapy Cool Path Bi-Directional Irrigated Ablation Catheter; U.S. Approval for Therapy Cool Path Irrigated Ablation Catheter.ST. PAUL St. Paul as a missionary he fearlessly confronts the “perils of waters, of robbers, in the city, in the wilderness.” [N.T.: II Cor. 11:26] See : Bravery , 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 expanded European CE Mark approval to include the Therapy[TM] Cool Path[TM] irrigated ablation catheter with bi-directional steering for use in ablation procedures to treat abnormal heart rhythms. This catheter is the first open-irrigated ablation catheter to provide bi-directional steering, a feature designed to help physicians maneuver the catheter in difficult areas of the heart and perform complex ablations more efficiently. "The main advantage of the bi-directional catheter is its ease of use in reaching difficult anatomical locations," said Carlo Pappone, M.D., Ph.D., F.A.C.C., director of the Arrhythmology Department at San Raffaele San Raffaele may refer to:
"We are excited to offer physicians the first bi-directional, open-irrigated catheter in the European market," said Peter Chen, president of Irvine Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. , Inc., a St. Jude Medical Company. "As the population ages, the demand for more effective treatment of cardiac arrhythmias will only increase." St. Jude Medical also 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 and release of the uni-directional Therapy[TM] Cool Path[TM] open-irrigated ablation catheter for use in patients with type 1 atrial flutter atrial flutter n. Rapid regular atrial contractions occurring usually at rates between 250 and 400 per minute and often producing saw-tooth waves in an electrocardiogram. Also called auricular flutter. . With atrial flutter, the heart's upper chambers beat steadily faster than normal, often resulting in a feeling of lightheadedness. Catheter ablation therapy catheter ablation therapy Cardiology A nonsurgical technique in which an electrode catheter is introduced into the veins of the arms or legs and advanced into the heart; if an abnormal electric pathway of depolarization is identified in the conduction is used by physicians to restore a normal heart rhythm in patients with cardiac arrhythmias. During the procedure, an electrophysiologist uses a catheter (a long narrow tube) to deliver radiofrequency energy to create lesions in specific areas of cardiac tissue. The lesions, or tiny scars, interrupt the abnormal electrical signals that contribute to erratic heart rhythms. An open-irrigated catheter distributes saline fluid into heart tissue through ports in the tip of the catheter to enhance cooling during ablation procedures. Cooling the tip of the catheter is designed to reduce the risk of undesirable tissue damage at the procedure site. Studies have shown that open-irrigated catheters safely and effectively create deeper and larger lesions while using less energy than standard therapy catheters. "We are pleased to expand and enhance our U.S. electrophysiology portfolio," said Michael T. Rousseau, president of St. Jude Medical's U.S. Division. "These products broaden St. Jude Medical's EP catheter and ablation system offerings, reflecting the Company's commitment to develop industry-leading technologies for treating many cardiac arrhythmias." St. Jude Medical's electrophysiology offerings include introducers, diagnostic catheters and cardiac mapping systems. The Therapy Cool Path irrigated catheters work in conjunction with St. Jude Medical's EnSite[R] System, a computer-based visualization technology that provides physicians three-dimensional graphical images of the heart and the location of the arrhythmia's origin, enabling them to navigate electrophysiology catheters in real time. 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 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. , 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., St. Jude Medical employs more than 11,000 people worldwide. For more information, please visit www.sjm.com. Forward-Looking Statements 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 potential clinical successes, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings, and market shares. 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 those described in the Company's Annual Report on Form 10-K Form 10-K A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information. Form 10-K See 10-K. filed on February 28, 2007 (see Item 1A on pages 13-20, and page 20 of Exhibit 13 to the Company's Form 10-K). 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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