BIOTRONIK Home Monitoring[R] Receives Industry's First Approval to Safely Replace Hospital Visits for Cardiac Device Follow-Ups.BERLIN -- BIOTRONIK SE & Co. KG, the pioneer of wireless remote monitoring (protocol) remote monitoring - (RMON) A network management protocol that allows network information to be gathered at a single computer. Whereas SNMP gathers network data from a single type of Management Information Base (MIB), RMON 1 defines nine additional MIBs that provide a technologies and leading manufacturer of implantable cardiac devices, today announced the Industry's first European CE Mark approval for its unique remote patient monitoring technology. BIOTRONIK Home Monitoring([R]) is now approved to safely replace in-hospital device follow-up visits. This new CE Mark follows the recently received equivalent 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 granted in May, 2009. BIOTRONIK Home Monitoring([R]) is the first and only fully wireless, mobile remote monitoring system for patients with implantable cardiac devices on the market today. This newly authorized EU approval for BIOTRONIK Home Monitoring([R]) is based on the landmark TRUST The Landmark Trust is a British building conservation charity, founded in 1965 by Sir John and Lady Smith, that rescues buildings of historic interest or architectural merit and then gives them a new life by making them available for holiday rental. Trial1,2 which proved that BIOTRONIK Home Monitoring([R]) can safely and effectively replace conventional in-hospital device follow-up visits. Patients can be remotely monitored securely through the BIOTRONIK Home Monitoring([R]) wireless system with only one annual in-clinic visit. In addition, the TRUST trial also demonstrated that BIOTRONIK Home Monitoring([R]) with its automatic daily surveillance provides early detection and notification of both symptomatic and asymptomatic arrhythmic ar·rhyth·mic adj. Lacking rhythm or regularity of rhythm. events and device system anomalies allowing for earlier physician intervention than conventional in-hospital follow-ups. By extending the time between routine in-hospital visits for periods up to 12 months, remote device follow-up with BIOTRONIK Home Monitoring([R]) reduces the number of physician consultations in often overburdened o·ver·bur·den tr.v. o·ver·bur·dened, o·ver·bur·den·ing, o·ver·bur·dens 1. To burden with too much weight; overload. 2. To subject to an excessive burden or strain; overtax. n. 1. cardiology cardiology Medical specialty dealing with heart diseases and disorders. It began with the 1749 publication by Jean Baptiste de Sénac of contemporary knowledge of the heart. Diagnostic methods improved in the 19th century, and in 1905 the electrocardiograph was invented. hospitals without negatively impacting patients' quality of care or safety. Physicians and clinic staff benefit from reduced workloads for routine cases, which allow them to afford greater attention to patients who urgently require a consultation for diagnostics and treatment. These new approvals are applicable across the entire BIOTRONIK product portfolio of pacemakers Pacemakers Definition A pacemaker is a surgically-implanted electronic device that regulates a slow or erratic heartbeat. Purpose Pacemakers are implanted to regulate irregular contractions of the heart (arrhythmia). , implantable cardioverter defibrillators (ICD ICD International Classification of Diseases (of the World Health Organization); intrauterine contraceptive device. ICD abbr. ) and cardiac resynchronization therapy (CRT (1) (C RunTime) See runtime library. (2) (Cathode Ray Tube) A vacuum tube used as a display screen in a computer monitor or TV. The viewing end of the tube is coated with phosphors, which emit light when struck by electrons. ) devices with BIOTRONIK Home Monitoring([R]). "BIOTRONIK has yet again shown its leadership in remote monitoring for cardiac device patients with these new EU and US approvals for our breakthrough BIOTRONIK Home Monitoring([R]) technology. We are committed to delivering advanced patient management solutions to clinicians by combining our quality cardiac device therapies and our unique remote monitoring technologies to improve patients' outcomes," stated Marlou Janssen, Vice President Global Marketing and Sales, 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. , BIOTRONIK. "By implementing BIOTRONIK Home Monitoring, physicians can enhance patient care while optimizing clinic efficiencies and workflows." BIOTRONIK's Home Monitoring technology has also just been nominated for the prestigious German Federal President's "Deutscher Zukunftspreis" (German Innovation Award) for its pioneering achievement in medical technology. About BIOTRONIK Home Monitoring([R]) BIOTRONIK was first to develop and introduce, an internet-based, wireless remote monitoring system using the GSM telephone network. Today, more than 230,000 BIOTRONIK Home Monitoring([R]) systems have been implanted, in more than 55 countries worldwide helping to optimize patient care. BIOTRONIK Home Monitoring([R]) is available across the entire BIOTRONIK product portfolio of pacemakers, ICD and CRT devices enabling remote device follow up at any time from anywhere in the world. More information: BIOTRONIK Home Monitoring About TRUST Trial Developed by a steering committee steer·ing committee n. A committee that sets agendas and schedules of business, as for a legislative body or other assemblage. steering committee Noun of electrophysiologists and cardiologists, with 1,443 patients enrolled from 105 North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. sites, TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) is the first and largest study to test remote monitoring and rapid detection of symptomatic and asymptomatic cardiac events in a prospective, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. trial. The study used BIOTRONIK Home Monitoring([R]), an automatic, fully wireless system that performs daily telemetric surveillance of the patient and the technical status of the implanted device, without requiring patient activation. About BIOTRONIK SE & Co. KG As one of the world's leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of 4,900 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide. More information: www.biotronik.com * N. Varma et al. Evaluation of efficacy and safety of remote monitoring for ICD follow-up: the TRUST trial. Circulation 2008;118;2309-2317, Abstract 4078. * N. Varma, et al, European Heart Journal 2009; 30 (Abstract Suppl.) Nr. 1909, P1656. Upon publication, please provide us with a copy. |
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