Sorin Group: ELA Medical, Inc. Enrolls First Patient in the NATURE Observational Study in the U.S.DENVER, Colo. -- Study Will Look Into the Evolution Of AV Conduction Disorders in Pacemaker Patients. ELA Noun 1. ELA - an extreme leftist terrorist group formed in Greece in 1971 to oppose the military junta that ruled Greece from 1967 to 1974; a revolutionary group opposed to capitalism and imperialism and the United States Revolutionary People's Struggle Medical, Inc., a Sorin Group company (MIL:SRN SRN (formerly in Britain) State Registered Nurse ) that specializes in the design and manufacture of implantable pacemakers and defibrillators, announced the first U.S. implant in NATURE, an observational study that will enroll 1,440 patients in North America and Europe. The objective of the NATURE study is to observe the evolution of atrio-ventricular conduction disorders in pacemaker patients over a 2-year time period. Patients implanted with either ELA Medical / Sorin Group's SYMPHONY(TM) model 2550 or REPLY(TM) DR (1) dual chamber pacemakers will be included in the study. Data will be collected using AIDA (language) AIDA - 1. A functional dialect of Dictionary APL by M. Gfeller. ["APL Arrays and Their Editor", M. Gfeller, SIGPLAN Notices 21(6):18-27 (June 1986) and SIGAPL Conf Proc]. 2. +(TM), ELA's exclusive feature that is capable of identifying different types of atrio-ventricular blocks. SYMPHONY(TM) pacemakers are equipped with AAIsafeR(TM), a unique algorithm designed to deliver right ventricular pacing only when needed. REPLY(TM) pacemakers incorporate the same algorithm. Excessive ventricular pacing has been shown to have harmful effects on the heart, increasing the patient's risk of developing heart failure and atrial fibrillation. The advantages of an algorithm that reduces unnecessary ventricular pacing, coupled with functions providing a detailed history of the course of heart block should offer a wealth of useful knowledge to physicians implanting pacemakers. The primary objective of the study will be to measure the incidence (frequency) of high degree heart block in patients with sinus node dysfunction sinus node dysfunction Cardiology A disturbance, impairment or defect in the behavior of the sinoatrial/SA node. See Sick sinus syndrome. or brady tachy syndrome. Sinus node disease is a disease of the heart's natural pacemaker which causes low intrinsic heart rates. Brady tachy syndrome is defined as an 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 originating in the atrium, the heart's upper chamber, formed by the alternation alternation /al·ter·na·tion/ (awl?ter-na´shun) the regular succession of two opposing or different events in turn. alternation of generations metagenesis. of various 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. fast rhythms with sinus bradycardia or sino-atrial block. The first US implant was performed by Dr. Linda Shuck, a cardiologist at Hugh Chatham Memorial Hospital in Elkin, North Carolina Elkin is a town in Surry County, North Carolina, along the Yadkin River. Elkin shares its name with the surrounding township of Elkin Township. The population was 4,109 at the 2000 census. Geography Elkin is located at (36. . The 70-year-old patient had sinus node dysfunction. "We hope that the NATURE study will help better identify indications for implant and provide more appropriate pacing modes to pacemaker patients. This study may provide information which will help both physicians and industry towards eliminating deleterious right ventricular pacing in conventional pacemakers," said Dr. Shuck. "Sorin Group is pleased to start the NATURE study in the U.S. This study reflects the importance that the company puts in the continuous improvement of treatment for pacemaker patients. Because the study of the evolution of AV conduction disorders can best be conducted on large numbers of patients and requires routine data collection, the NATURE observational study is expected to yield valuable findings on AV conduction disorders that may eventually lead to significant changes in the way pacemaker patients are treated", said Dick Ames Senior Vice President, U.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. (CRM (Customer Relationship Management) An integrated information system that is used to plan, schedule and control the presales and postsales activities in an organization. ), ELA Medical, Inc. (1) The REPLY pacemaker was released in the European market in May 2007. The device is not available for distribution in the United States. Regulatory clearance of REPLY(TM) pacemakers in the U.S. is planned in early 2008. ELA Medical, Inc. ELA Medical, Inc., part of Sorin Group, is headquartered in Denver, Colorado. The company designs and manufactures implantable pacemakers and ICDs, leads, and Holter equipment and markets them in the U.S. About the Sorin Group: The Sorin Group (Bloomberg: SRN.IM; Reuters: SORN.MI), a world leader in the development of medical technologies for cardiac surgery, offers innovative therapies for cardiac rhythm dysfunctions, interventional cardiology and the treatment of chronic kidney diseases. The Sorin Group includes: Dideco, CarboMedics, Inc., COBE COBE: see infrared astronomy. Cardiovascular, Inc., Stockert, Mitroflow, ELA Medical, Inc., Sorin Biomedica, Bellco and Soludia. It has more than 4,500 employees working at facilities in more than 80 countries throughout the world to serve over 5,000 public and private treatment centers. For more information, please visit our web site: www.sorin-crm.com or www.sorin.com. |
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