Barcelona, Spain, and Berlin, Germany, August 31, 2009 - BIOTRONIK SE & Co. KG, the pioneer of wireless remote monitoring technologies and leading manufacturer of implantable cardiac devices, today announced that new data from the TRUST (Lumos-T Safely Reduces Routine Office Device Follow Up) trial1 presented at the European Society of Cardiology Congress 2009 demonstrate the benefits of BIOTRONIK Home Monitoring in the early detection of patient clinical events as well as the safe reduction of in-office follow-up visits.
BIOTRONIK Home Monitoring is the first and only fully wireless, mobile remote monitoring system for patients with implantable cardiac devices on the market today and now there is further clinical evidence to support its use in daily practice.
The new data from the TRUST trial reported that BIOTRONIK Home Monitoring can safely and effectively replace conventional in-office device follow-up visits. Patients can be monitored safely through the BIOTRONIK Home Monitoring wireless system with only one annual in-office visit.2
The TRUST trial also concluded that BIOTRONIK Home Monitoring with automatic daily surveillance provides early detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling earlier physician intervention. Patients were evaluated earlier by their physician when significant changes occurred in their implanted devices or clinical condition. Remote monitoring event notifications were evaluated in a median of 3 days compared to more than 30 days with conventional care.3
Moreover, the trial showed that the event notifications generated from the BIOTRONIK Home Monitoring system provided accurate information, even for silent clinical events (e.g. asymptomatic atrial fibrillation) of which the patients were unaware.3 At the same time, despite daily remote monitoring, the event notifications were triggered infrequently and do not overburden physicians’ or clinic resources with unnecessary or distracting information.
“There has been a call from the medical community for remote monitoring of patients with implantable cardiac devices. TRUST is the first prospective large scale (1,443 patients) clinical trial to test this technology. TRUST demonstrated that BIOTRONIK Home Monitoring, which is an advanced automatic remote monitoring system, can streamline hospital visits and enhance surveillance for important device- or patient-related clinical data. These results have important implications for improved patient safety,” stated Niraj Varma, M.D., Ph.D., TRUST Principal Investigator, Cleveland Clinic, Cleveland, Ohio, USA.
1. 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.
2. N. Varma et al. Efficiency of calendar based ICD checks: conventional follow-up compared to remote monitoring in the TRUST trial. ESC Congress, Barcelona, Spain, August 30, 2009, Abstract 86114.
3. N. Varma et al. Event notification by remote monitoring systems performing automatic daily checks: load, characteristics and clinical utility. ESC Congress, Barcelona, Spain, August 31, 2009, Abstract 87438.
About the TRUST Trial
Developed by a steering committee of electrophysiologists and cardiologists, with 1,443 patients enrolled from 105 North American 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 trial. The study used BIOTRONIK Home Monitoring®, 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 Home Monitoring®
Over eight years ago, BIOTRONIK was first to develop and introduce, an internet-based, wireless remote monitoring system using the GSM telephone network.
Today, more than 200,000 BIOTRONIK Home Monitoring systems have been implanted, in more than 65 countries worldwide helping to optimize patient care. All BIOTRONIK pacemakers, ICD and CRT devices are compatible with the BIOTRONIK Home Monitoring system which allows remote device follow up at any time from anywhere in the world.
About BIOTRONIK SE & 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 4,800 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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