Press release

TRUST Trial Confirms Early Detection of Cardiac Events Using ICDs with Remote Monitoring

Boston, Mass. – May 15, 2009 – BIOTRONIK Inc., the pioneer in wireless remote monitoring technology for patients with cardiac devices, announced today that data presented by Niraj Varma, MD, PhD, FRCP, at the Heart Rhythm Society’s Annual Scientific Sessions verifies that the secondary endpoints of the landmark TRUST trial have been met.

Dr. Varma’s abstract, Early Detection of ICD Events Using Remote Monitoring: the TRUST Trial, reported that the median time from onset to evaluation for all arrhythmias, including atrial fibrillation, ventricular tachyarrhythmia, and ventricular fibrillation, was significantly lower in patients with BIOTRONIK Home Monitoring®, compared to patients followed via conventional in-office follow-ups (less than 3 days versus more than 30 days, respectively). The study concluded that remote monitoring with automatic daily surveillance provides rapid detection and notification of both symptomatic and asymptomatic arrhythmic events, enabling early physician evaluation.

Developed by a steering committee of U.S. electrophysiologists and cardiologists, and enrolling 1,443 patients in 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, wireless system that performs daily telemetric surveillance of the patient and the technical status of the implanted device, without requiring patient activation.

“The data demonstrates yet another benefit the BIOTRONIK Home Monitoring system brings to patients, as well as physicians,“ said Dr. Varma. “Based on the results from this large-scale clinical trial, I believe that remote monitoring may improve physicians’ ability to care for patients with implanted cardiac devices and enhance patient safety.” Dr. Varma is TRUST principal investigator at the Cleveland Clinic in Cleveland, Ohio.
 

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 4,500 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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