FDA Approval of Medtronic Kappa 900 Pacemaker Strengthens World's Most Popular Pacemaker Line; Kappa 900 Now Features Atrial Monitoring and Diagnostic Capabilities.Business Editors & Health/Medical Writers MINNEAPOLIS--(BW HealthWire)--Dec. 17, 2001 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 approval by the U.S. Food and Drug Administration of the Medtronic Kappa(R) 900 series cardiac pacemakers, featuring new 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. monitoring and diagnostic functions to help physicians make more precise patient management decisions. This pacemaker represents the next generation of the Medtronic Kappa(R) family, the world's most-prescribed pacemakers. The Kappa family provides premier bradyarrhythmia therapies that treat patients with chronic heart problems in which the heart beats too slowly to adequately support the body's circulatory needs. In addition, the Kappa 900 now offers expanded monitoring information of the atria Atria The heart has four chambers. The right and left atria are at the top of the heart and receive returning blood from the veins. The right and left ventricles are at the bottom of the heart and act as the body's main pumps. (upper chambers) and ventricles Ventricles The two chambers of the heart that are involved in pumping blood. The right ventricle pumps blood into the lungs to receive oxygen. The left ventricle pumps blood into the circulation of the body to deliver oxygen to all of the body's organs and tissues. (lower chambers) that is easy to interpret and enables physicians to more efficiently assess atrial rhythm control and ventricular rate control. This new diagnostic information can result in more confident patient management decisions by physicians and shorter follow-up visits for patients. "Collection and presentation of this kind of information is a first in the industry," said Steve Mahle, president of 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. . "It reflects Medtronic's continued commitment to providing products that not only deliver superior therapies, but also help physicians better understand and treat current and evolving patient conditions." Kappa 900 pacemakers, which will be market released globally in early January, offer the full Kappa family suite of arrhythmia arrhythmia (ārĭth`mēə), disturbance in the rate or rhythm of the heartbeat. Various arrhythmias can be symptoms of serious heart disorders; however, they are usually of no medical significance except in the presence of management tools and patient safety features, plus new arrhythmia diagnostics and monitoring information, such as: -- Cardiac Compass(TM) trending information, which provides daily atrial fibrillation measurements to assess atrial rhythm control. This information can improve a physician's ability to track disease progression, as well as the effectiveness of current device and drug therapies. -- Monitoring of the ventricular rate during an atrial arrhythmia (Opposite Chamber monitoring), which helps assess ventricular rate control. This information can be viewed in a graphical snapshot format (called a rate histogram) or by viewing the specific episode EGM information. Kappa 900 has expanded its EGM storage capability to three times more than previous Kappa models. -- Specific information on the frequency and duration of arrhythmias, which help with risk assessment of symptoms and in determining whether a change in anticoagulation medicines is warranted. -- Enhancements to Ventricular Capture Management(TM), which help manage pacing thresholds automatically and more reliably. Medtronic plans to launch an unprecedented number of new Cardiac Rhythm Management products over the coming months, including a new family of defibrillators, a unique ablation catheter, a new programmer with remote viewing capabilities that will serve all Medtronic CRM (Customer Relationship Management) An integrated information system that is used to plan, schedule and control the presales and postsales activities in an organization. devices and several heart failure products. Last month, the company launched the Sprint Quattro Secure(TM) steroid-eluting right ventricular lead ventricular lead Cardiology A pacing lead placed in or on the ventricle. See Lead. Cf Atrial lead. for use with implantable cardioverter-defibrillators. Medtronic, Inc., headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address 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 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. for the year ended April 27, 2001. Actual results may differ materially from anticipated results. |
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