New trial data shows that BIOTRONIK monitoring system is safe and effective for detecting patients' clinical events

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) trial 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.

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.

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.