BIOTRONIK publishes final results of landmark TRUST Trial in Circulation

BIOTRONIK, the pioneer of wireless remote monitoring technologies and leading manufacturer of implantable cardiac devices, announced today that the final results of the landmark TRUST Trial (Lumax-T/Lumos-T Safely RedUceS RouTine Office Device Follow-Up) have been published in the July 27, 2010 issue of Circulation. BIOTRONIK Home Monitoring^® is the industry's first and most advanced wireless remote monitoring system for patients with cardiac devices.

“Automatic remote monitoring is an exciting new technology that holds many promises. TRUST is the first large study to test it in patients with ICDs. The TRUST results unequivocally establish remote monitoring as a highly effective method of follow-up”

The article, "Efficacy and Safety of Automatic Remote Monitoring for ICD Follow-Up: The TRUST Trial," demonstrates significant benefits of Home Monitoring^® in the safe reduction of conventional clinic follow-up visits, as well as in the early detection of patient clinical events, including asymptomatic atrial fibrillation. Further, Home Monitoring^® can extend the time between routine in-office follow-ups, and is the only system having FDA and CE approval to claim these benefits.

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 cardiac rhythm management study to prove remote monitoring and rapid detection of symptomatic and asymptomatic cardiac events in a prospective, randomized trial. TRUST used BIOTRONIK Home Monitoring^®, an automatic, wireless system that performs daily telemetric surveillance of the patient and reports the technical status of the implanted device without requiring patient activation.

"Automatic remote monitoring is an exciting new technology that holds many promises. TRUST is the first large study to test it in patients with ICDs. The TRUST results unequivocally establish remote monitoring as a highly effective method of follow-up," said Dr. Niraj Varma, Cardiac Pacing & Electrophysiology, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, and TRUST National Principal Investigator. "Patients' safety is enhanced by enabling prompt medical care if problems occur in either their clinical condition or in their devices. At the same time, the need for regular in-clinic follow-up is virtually halved. I believe, from these results, that remote monitoring will improve the way physicians care for patients with all forms of implantable electronic cardiac devices."

"TRUST firmly establishes remote monitoring as a safe and effective method of following patients and their ICD systems," said Dr. Andrew Epstein, Professor of Medicine, Electrophysiology Section, Cardiovascular Division, at the University of Pennsylvania, and TRUST Principal Investigator. "For patients and physicians who want home follow-up, TRUST provides the evidence base needed to support its prescription. Furthermore, remote monitoring has the potential for enhancing safety by giving patients immediate access to medical care when arrhythmia or device integrity issues arise."

BIOTRONIK Home Monitoring^® provides daily updates of patients' cardiovascular conditions and the status of their implanted devices. When clinically significant events occur, such as critical abnormalities in the heart's rhythm, or when changes occur in device status, Home Monitoring^® automatically sends an alert message to a secure internet-based system. The physician then is immediately able to read a high-definition intracardiac electrocardiogram and other decision-critical information through the Home Monitoring^® system.

Home Monitoring^® allows patients to be monitored continuously and wirelessly by their physician, from anywhere in the world with any computer having an internet connection. Unlike other systems that require cardiac device patients to activate remote monitoring, sometimes using complicated technology, Home Monitoring^® is fully automatic, wireless and mobile, and requires no patient intervention.

"Decreasing the number of non-actionable, scheduled and unscheduled office visits through remote monitoring significantly eases the pressure of overloaded follow-up cardiac clinics. This permits physicians to focus on patients who actually require intervention," stated Dr. Charles Love, Professor of Medicine and Director of Cardiac Rhythm Device Services, The Ohio State University, and TRUST Principal Investigator.

"TRUST is just one example of BIOTRONIK's commitment to be a leader in clinical excellence by investing in clinical research of clear significance and rigorously running trials to achieve unquestionable endpoint conclusions," said Kevin Mitchell, BIOTRONIK Vice President, Clinical Studies. "We strive to further advance patient care by exploring unanswered questions and unmet needs. Other trials of landmark potential that are sponsored by BIOTRONIK include REPLACE, IMPACT, and EchoCRT."

BIOTRONIK Home Monitoring^®, an innovation in cardiac device technology pioneered by BIOTRONIK, just celebrated its 10-year anniversary of industry leadership at a world-renowned cardiology conference in Nice, France.