Lake Oswego, Ore., and Berlin, Germany – September 9, 2010 – BIOTRONIK, pioneer of the industry’s first and most advanced wireless remote monitoring technologies and leading manufacturer of premium implantable cardiac devices, announced today that the results from the landmark TRUST Trial (Lumax-T/Lumos-T Safely Reduces Routine Office Device Follow-up) were recently published online and will be published in the October 13, 2010 issue of Circulation Arrhythmia and Electrophysiology.
The new publication, “Automatic Remote Monitoring of ICD Lead and Generator Performance: The TRUST Trial,” demonstrates the significant benefits of BIOTRONIK Home Monitoring® in the automatic early detection of ICD generator and lead performance, as well as asymptomatic arrhythmias. Furthermore, the technology has been demonstrated to extend the time between routine in-office follow-ups. BIOTRONIK Home Monitoring® is the only commercially available system on the market today having FDA and CE approval to claim these benefits.
“A mechanism for effective monitoring the performance of implantable cardiac devices has been demanded by both patients and the physician implanting community. This study in patients with ICDs, from the TRUST trial, shows that automatic remote monitoring, which provides near continuous remote surveillance is a rigorous method of follow up,” said Dr. Niraj Varma, Cardiac Pacing & Electrophysiology, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio and TRUST National Principal Investigator. “By self-declaring system problems, even when the patient was unaware of them, remote monitoring was superior to conventional in-person scheduled hospital checks. It permitted prompt physician intervention, as and when required, for example, to change programming or cardiac medications, or replace a component if necessary, though this was rare since the implantable systems used were shown to be very reliable. This home monitoring method enhances patients’ safety and provides assurance for both patients and their physicians.”
Developed by a steering committee of U.S. electrophysiologists, with 1,450 patients enrolled and randomized in 102 North American sites, TRUST is the first large-scale, prospective, randomized cardiac rhythm management study to demonstrate that remote monitoring allows rapid detection of symptomatic and asymptomatic arrhythmias.
“TRUST established remote monitoring as a safe and effective method of following patients and their ICD systems. The present study confirms that although ICD lead and generator malfunction is rare, in contrast to conventional three-month checks, daily remote monitoring is able to immediately identify and alert physicians to the need for medical assessment,” said Dr. Andrew E. Epstein, Professor of Medicine at the University of Pennsylvania and Chief, Cardiology Section, Philadelphia VA Medical Center. “Importantly, even in the absence of symptoms, remote monitoring can deliver alerts before potentially life-threatening complications become grossly apparent, such as lead fracture causing inappropriate shocks. This technology offers the promise of using not only isolated data but also trends for the assessment of lead and device performance. By decreasing morbidity, patients’ quality of life will almost certainly be enhanced.”
Unlike other systems that require patients to manually initiate remote monitoring, sometimes using complicated technology, BIOTRONIK Home Monitoring® is fully automatic, continuous, conveniently wireless and mobile, and requires no patient intervention. When a clinically significant event occurs, such as an abnormal change in the heart’s rhythm, an alert message is sent to a secure internet-based system. The physician has regular access to this decision-critical information, including high-definition intracardiac electrocardiograms1, from anywhere in the world with any computer having an internet connection.
“This publication further demonstrates the promise of Home Monitoring® by analyzing the vast data set obtained during the TRUST study,” said Kevin Mitchell, BIOTRONIK Vice President, Clinical Studies. “Several future publications are being planned with our publication committee utilizing this data set. BIOTRONIK will continue to sponsor rigorous and scientifically valid clinical trials that can help our physician partners to better care for their patients.”
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 over 5,100 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.
1 Intracardiac electrocardiogram -- a trace representing the heart’s electrical activity that is similar to an ECG, but taken from inside the heart.
Upon publication, please provide us with a copy.