St. Jude Medical Announces FDA Approval and Market Launch of New Cardiac Ablation Generator and Therapy(TM) Catheters.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 and market release of the IBI-1500T6 Cardiac Ablation Generator and Therapy(TM) electrophysiology (EP) catheters, expanding the Company's therapeutic EP portfolio with a new high-power, state-of-the-art ablation system. "The introduction of the IBI-1500T6 radiofrequency (RF) generator and Therapy Dual 8(TM) family of ablation catheters demonstrates our commitment to ablation technology in the United States," said Dr. Peter Chen, president of St. Jude Medical's 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. business, acquired by the Company in October 2004. "These new products are based on proven technology already available in other international markets, and are designed to support future catheter ablation Catheter Ablation Definition Catheter ablation of an irregular heartbeat involves having a tube (a catheter) inserted into the heart through which electrical energy is sent to either reset the heartbeat or stop the heart from beating so a mechanical platforms." Ablation procedures are common in the treatment of cardiac arrhythmias, which affect approximately 5.3% of the U.S. adult population, or over 14 million people. Non-surgical ablation therapy ablation therapy See Ablation–cardiology. is often recommended to "disconnect" or "isolate" the pathway of these abnormal rhythms, which, if left untreated, can lead to stroke or heart failure. "We are pleased to expand and enhance our U.S. electrophysiology portfolio for treating cardiac arrhythmias," 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." The high-power IBI-1500T6 Cardiac Ablation Generator (delivering up to 100 watts of RF power) is a microprocessor-controlled instrument offering a user-friendly platform for programming all procedure-related settings. During a procedure, the 1500T6 monitors all critical performance variables, such as power output, tissue temperature, impedance (similar to electrical resistance) and ablation time. Temperature and impedance from the catheter tip electrode tip electrode Cardiac pacing The distal–usually, stimulating–electrode in a bipolar, transvenous pacing lead system. Cf Ring electrode. are updated continuously to offer maximum user control. Sophisticated signal filtering, which eliminates unwanted frequencies, results in continuous intracardiac intracardiac /in·tra·car·di·ac/ (-kahr´de-ak) within the heart. in·tra·car·di·ac adj. Within the heart. intracardiac within the heart. electrogram recording (a measurement of electrical activity by placing electrodes on or in the heart) during monitoring and ablation modes. Therapy(TM) ablation catheters are available in two models, both fully compatible with the high-powered IBI-1500T6 Cardiac Ablation Generator. Both models support a full range of physician requirements with six distinct curve sizes for varying patient anatomies and procedure locations, and a comfortable, ergonomic steering mechanism. A proprietary Pebax(R) catheter shaft provides torque, flexibility and stability, facilitating catheter placement and its subsequent manipulation in the heart during EP procedures. The Therapy(TM) Dual-8(TM) ablation catheters are designed with an 8mm tip electrode containing dual temperature sensors to allow measurement of temperature variance across the entire ablation electrode. The longer tip electrode is intended to reduce ablation procedure time when creating long, linear lesions in the treatment of 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. . The 4mm tip Therapy(TM) ablation catheters, currently on the U.S. market, offer a reliable and accurate single sensor temperature monitoring system for the treatment of supraventricular tachycardias. The IBI-1500T6 automatically limits RF delivery to a maximum power output of 50 watts when used with a 4mm tip ablation electrode. 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. 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 Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. filed on November 8, 2005 (see page 35). Actual results may differ materially from anticipated results. Pebax is a registered trademark of Atochem Corporation. |
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