September 26, 2008
The New BIOTRONIK Home Monitoring(R) Approved in Europe
BIOTRONIK GmbH & Co KG, the pioneer in wireless remote monitoring technology for patients with cardiac devices, today announced CE Mark approval of the newest generation of BIOTRONIK Home Monitoring(R), the most advanced remote monitoring technology of its kind. Using an intelligent traffic light system, BIOTRONIK Home Monitoring quickly and easily identifies patients with the most clinically relevant events to streamline clinic workflow and improve patient care.
Over seven years ago, BIOTRONIK was first to develop and introduce, an internet-based remote monitoring system using the GSM telephone network and the only cardiac device manufacturer to make this technology available across its entire product portfolio of pacemakers, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices allowing physicians to remotely monitor their patients' clinical and device status from anywhere in the world. In fact, BIOTRONIK Home Monitoring is the only system available on the market that enables remote device follow up at any time.
Continuing its leadership in pioneering telecardiology, the newly approved BIOTRONIK Home Monitoring platform leads the industry in technological advancements. BIOTRONIK Home Monitoring has integrated a traffic-light, severity-based display of patients' status to easily identify the most important information with just one click, allowing physicians to quickly review the clinical status of patients at a glance. The system provides one continuously updated and consolidated online CardioReport which includes physicians' acknowledgements and review actions to minimize alert notifications to the most clinically relevant. Easy to read clinical information, including heart failure and atrial fibrillation diagnostics, an intracardiac electrogram, IEGM-Online HD(R), (a tracing representing the heart's electrical activity similar to an ECG but taken from inside the heart) as well as information related to device integrity is automatically available on the BIOTRONIK Home Monitoring system. Physicians can also customize alert-parameters on an individual or group patient basis, via the secured website, to ensure consistent patient triage. In addition, using BIOTRONIK Home Monitoring physicians and clinics can establish collaborative care management networks to optimize cardiovascular patient coordination and to enhance workflow efficiencies within one or more clinics.
Today, more than 130.000 BIOTRONIK Home Monitoring systems have been implanted, in more than 50 countries worldwide helping to optimize patient care management in more than 2,700 clinics. All BIOTRONIK pacemakers, ICD and CRT devices are compatible with the new BIOTRONIK Home Monitoring system which allows remote device follow up at any time without pre-scheduling patients. In between routine office follow-up, the automatic, continuous Home Monitoring ensures the early detection of clinical relevant cardiovascular events.
BIOTRONIK has also established a large, multinational clinical trial program to provide even more evidence that Home Monitoring can improve patient care and at the same time, optimize clinic resources. Two of these studies are particularly noteworthy, namely, IMPACT and TRUST. The IMPACT trial, the largest Home Monitoring study worldwide, enrolling over 2,700 patients investigates whether the risk of stroke can be reduced in ICD and CRT patients with asymptomatic atrial fibrillation by early detection of these arrhythmias utilizing BIOTRONIK Home Monitoring technologies and a predefined anticoagulation plan. IMPACT study results should demonstrate that Home Monitoring has the potential to improve patients' wellbeing far beyond identification of asymptomatic atrial fibrillation episodes. The TRUST study examines the effectiveness of using BIOTRONIK Home Monitoring to remotely monitor patients with the Lumax(R) or Lumos(R) ICDs compared to periodic in-office follow-up. TRUST also assesses using Home Monitoring and the unique BIOTRONIK ICD device features to quickly detect atrial fibrillation and other arrhythmic events. Importantly, TRUST enrolment was completed early and therefore, the study results are planned to be announced at the upcoming American Heart Association Scientific Sessions in November.
"With this important European approval of our new BIOTRONIK Home Monitoring system, our leadership in telecardiology for patient with cardiac devices has been reconfirmed", commented, Marlou Janssen, Vice President Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. "We will launch the new BIOTRONIK Home Monitoring platform at the beginning of October with limited availability to selected clinics throughout the world and complete the launch process in early 2009. We are proud to provide physicians with this state-of-the-art, wireless, remote monitoring technology designed to enhance patient care and optimize clinic resources."
About BIOTRONIK Home Monitoring(R)
Home Monitoring is an innovation in cardiac device technology pioneered by BIOTRONIK. It allows patients to be monitored continuously and wirelessly by their physician from anywhere in the world and from any computer with an Internet connection. Home Monitoring is automatic, mobile and requires no patient intervention. BIOTRONIK Home Monitoring provides daily updates of the patient's cardiovascular condition and the status of the implanted cardiac device. When a clinically significant event occurs, including, critical alterations in the heart's rhythm or changes in device status such as low battery, BIOTRONIK Home Monitoring automatically sends an alert notification to a secure Internet-based system. The physician is then able to rapidly and easily review the patient clinical information and, if needed, make the appropriate adjustments to medication or device therapy to avoid further deterioration of the patient's condition. Home Monitoring also saves patient time and clinic resources by potentially eliminating routine in-office follow-up.
About BIOTRONIK GmbH & Co. KG
As one of the world's leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4000 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.
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