Medtronic Announces First Implants of Its EnPulse Pacing System; World's First Fully Automatic Pacemaker is Designed to Optimize Therapy and Simplify Care.Business Editors/Health/Medical Writers MINNEAPOLIS--(BUSINESS WIRE)--May 15, 2003 Medtronic, Inc. (NYSE NYSE See: New York Stock Exchange :MDT MDT abbr. Mountain Daylight Time MDT (in the US and Canada) Mountain Daylight Time MDT n abbr (US) (= mountain daylight time) → ) today announced the first uses of the Medtronic EnPulse(TM) pacing system in several patients to begin a clinical evaluation clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy of this new device for slow-beating hearts. The device is designed to continuously measure changes in the heart's upper and lower chamber threshold levels -- the minimum level of electricity that needs to be delivered to stimulate a heart beat -- and, as necessary, automatically adjust the amount of pacing output that is delivered to both chambers. The clinical trial will evaluate the safety and ability of the EnPulse system to help physicians better manage pacing therapy and simplify follow-up care for patients. The new Medtronic EnPulse system is the first in a new generation of Medtronic pacemakers and builds upon on the success of the predecessor Medtronic Kappa(R) pacemaker family, the world's most prescribed pacemakers. The beginning of the Medtronic EnPulse clinical evaluation included system implants in 11 patients on May 12, 2003 by: Dr. Sperzel of Kerckhoff Klinik in Bad Nauheim Bad Nauheim (bät nou`hīm), town (1994 pop. 29,405), Hesse, central Germany, in the Taunus Mts. It is a world-famous resort, noted for its salt springs, which are used to treat heart and nerve diseases. , Germany; Prof. Tscheliessnigg of Universitatsklinik Graz, in Graz, Austria; Dr. Brandt of Lund University Lund University has 7 faculties, with additional campuses in the cities of Malmö and Helsingborg, with a total of over 42,500 people studying in 50 different programmes and 800 separate courses. Hospital in Lund, Sweden; and Dr. Milasinovic of Clinical Center of Serbia, Belgrade, Yugoslavia. "The EnPulse system is the first device in a new generation of stimulation systems designed to constantly regulate the delivery of pacing output. The potential to review comprehensive device information on one programmer screen during patient follow-up sessions may lead to more efficiency, more time to focus on the patient instead of the device, and more confidence in the system," said Dr. Sperzel. Physicians at approximately 25 medical institutions worldwide will be involved in the clinical evaluation of the EnPulse pacemakers during the next few months. The features being evaluated in the trial include: -- Atrial atrial /atri·al/ (a´tre-al) pertaining to an atrium. a·tri·al adj. Of or relating to an atrium. Atrial Having to do with the upper chambers of the heart. Capture Management (ACM (Association for Computing Machinery, New York, www.acm.org) A membership organization founded in 1947 dedicated to advancing the arts and sciences of information processing. In addition to awards and publications, ACM also maintains special interest groups (SIGs) in the computer field. ): ACM, a function exclusive to the Medtronic EnPulse system, is intended to automatically adjust impulses for optimal stimulation of the heart's upper right chamber (atrium). It complements Ventricular Capture Management, which is available in the Medtronic Kappa devices and has a similar function to optimize stimulation in the heart's lower right chamber (ventricle ventricle /ven·tri·cle/ (ven´tri-k'l) a small cavity or chamber, as in the brain or heart.ventric´ular ventricle of Arantius the rhomboid fossa, especially its lower end. ). The EnPulse device is the only pacemaker system that is designed to automatically deliver adaptive threshold management in both chambers of the heart. For physicians, ACM capabilities may reduce the need for manual threshold testing and thus potentially provide faster patient follow up. -- Search AV +: The EnPulse system uses an automatic and expanded search method intended to sense the patient's natural heartbeats before delivering pacing therapy, which could reduce unnecessary stimulation impulses in the ventricle. Recent clinical studies have suggested that reducing this pacing stimulation may reduce the patient's risk of developing heart failure. In addition, by reducing these impulses, the longevity of the device may be extended. -- Quick Look II screen: This new user interface with the device will allow clinicians to look at one programmer screen during a patient's device check appointment and instantly access complete information about the patient and device. In addition, new trend monitoring capabilities may reduce the amount of time needed to gather key information and shorten patient office visits. "We are excited to begin this trial and hope to offer the EnPulse device as the premier system in Medtronic's new pacing product line in the coming months," said Steve Mahle, president, Medtronic 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. . "Bringing Atrial Capture Management into clinical evaluation is another significant milestone in our continued leadership in developing new treatment options for patients with bradycardia bradycardia: see arrhythmia. ." Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address There are two kinds of addresses that are widely used on the Internet. One is a person's e-mail address, and the other is the address of a Web site, which is known as a URL. Following is an explanation of Internet e-mail addresses only. For more on URLs, see URL and Internet domain name. is www.medtronic.com. Any statements made about the company's anticipated financial results and regulatory approvals are forward-looking statements subject to risks and uncertainties such as those described in Medtronic'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. for the year ended April 26, 2002. Actual results may differ materially from anticipated results. |
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