Press release

Randomized study of telemedicine in patients with cardiac devices

Lake Oswego, OR—March 18, 2008 — BIOTRONIK, the pioneer in fully automated, remote device patient management known as Home Monitoring®, announced today that the recruitment phase of the TRUST Study (Lumos-T Safely Reduces Routine Office Device Follow Up) was completed early.

The study was designed by an independent steering committee comprised of eight prominent electrophysiologists and is supported by a research grant from BIOTRONIK, Inc. The TRUST study is registered on clinicaltrials.gov. TRUST is a randomized, multicenter trial of patients with implantable cardioverter defibrillators (ICD) using BIOTRONIK Lumos and Lumax devices. The TRUST study will evaluate the effectiveness of using Home Monitoring® technology to follow-up patients compared to periodic in-office follow-up. In addition, the TRUST study will assess using Home Monitoring and unique BIOTRONIK device features to quickly detect atrial fibrillation and other arrhythmic events.

Anand Irimpen, MD, Associate Professor of Medicine at Tulane University Medical Center in New Orleans, Louisiana enrolled the 1,515th patient, meeting the study’s enrollment criteria stated, “As indicated by the rapid completion of enrollment in the TRUST study, Home Monitoring® could soon become an essential part of patient care. Home Monitoring provides patients with a sense of well-being and confidence, while it affords the physician a means of providing a continuum of care without the need to see the patient. I commend BIOTRONIK for this innovative step. The outcome of the TRUST study will provide important insight into the clinical management of patients with cardiac devices”.

Niraj Varma, MD, FRCP, Associate Professor of Medicine at Loyola University Medical Center, Chicago, IL, and the TRUST study, Primary Investigator commented, "Completion of enrollment in this ground-breaking study marks a significant milestone in the remote monitoring of implantable cardiac devices. We eagerly await the results, which will indicate the utility and impact of Home Monitoring technologies in modern clinical practice. Results from the first phase should be available by year end."
“BIOTRONIK is pleased with the positive response to the TRUST Study, which underscores the importance of wireless remote patient monitoring to the medical community.” said Jake Langer, President of BIOTRONIK, Inc.

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. Unlike other systems which require cardiac device patients to activate remote monitoring (sometimes using complicated technology), Home Monitoring is automatic, mobile and requires no patient intervention. Home Monitoring provides daily updates of the patient’s cardiovascular condition and the status of the implanted device. When a clinically significant event occurs (critical alterations in the heart’s rhythm or changes in device status such as low battery), Home Monitoring® automatically sends an alert message to a secure Internet-based system. The physician is then able to immediately read an intracardiac electrogram (a tracing representing the heart’s electrical activity similar to an ECG but taken from inside the heart) through the Home Monitoring system. BIOTRONIK´s Lumos and Lumax ICDs are the only devices available in the world with this remote monitoring technology.



About BIOTRONIK

As one of the world’s leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is present in all world markets. Known for having its finger on the pulse of the medical community, BIOTRONIK helps to assess the challenges physicians face, and provides the best solutions, be it cardiac implants, minimal invasive devices or other products and services ranging from diagnosis to electrotherapy and vascular intervention or therapy 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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