Cardiac Device Follow-Ups Approval

BIOTRONIK SE & Co. KG, the pioneer of wireless remote monitoring technologies and leading manufacturer of implantable cardiac devices, received the industry`s first European CE Mark approval for its unique remote patient monitoring technology.

BIOTRONIK Home Monitoring is now approved to safely replace in-hospital device follow-up visits. This new CE Mark follows the recently received equivalent FDA approval granted in May, 2009. BIOTRONIK Home Monitoring is the first and only fully wireless, mobile remote monitoring system for patients with implantable cardiac devices on the market today.

This newly authorized EU approval for BIOTRONIK Home Monitoring is based on the landmark TRUST Trial1,2 which proved that BIOTRONIK Home Monitoring can safely and effectively replace conventional in-hospital device follow-up visits. Patients can be remotely monitored securely through the BIOTRONIK Home Monitoring wireless system with only one annual in-clinic visit. In addition, the TRUST trial also demonstrated that BIOTRONIK Home Monitoring with its automatic daily surveillance provides early detection and notification of both symptomatic and asymptomatic arrhythmic events and device system anomalies allowing for earlier physician intervention than conventional in-hospital follow-ups.

By extending the time between routine in-hospital visits for periods up to 12 months, remote device follow-up with BIOTRONIK Home Monitoring reduces the number of physician consultations in often overburdened cardiology hospitals without negatively impacting patients' quality of care or safety. Physicians and clinic staff benefit from reduced workloads for routine cases, which allow them to afford greater attention to patients who urgently require a consultation for diagnostics and treatment. These new approvals are applicable across the entire BIOTRONIK product portfolio of pacemakers, implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices with BIOTRONIK Home Monitoring.

"BIOTRONIK has yet again shown its leadership in remote monitoring for cardiac device patients with these new EU and US approvals for our breakthrough BIOTRONIK Home Monitoring technology. We are committed to delivering advanced patient management solutions to clinicians by combining our quality cardiac device therapies and our unique remote monitoring technologies to improve patients` outcomes," states Marlou Janssen, VP Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. "By implementing BIOTRONIK Home Monitoring, physicians can enhance patient care while optimizing clinic efficiencies and workflows."

BIOTRONIK`s Home Monitoring technology has also just been nominated for the prestigious German Federal President`s "Deutscher Zukunftspreis" (German Innovation Award) for its pioneering achievement in medical technology. About BIOTRONIK Home Monitoring BIOTRONIK was first to develop and introduce, an internet-based, wireless remote monitoring system using the GSM telephone network.

Today, more than 230,000 BIOTRONIK Home Monitoring systems have been implanted, in more than 55 countries worldwide helping to optimize patient care. BIOTRONIK Home Monitoring is available across the entire BIOTRONIK product portfolio of pacemakers, ICD and CRT devices enabling remote device follow up at any time from anywhere in the world. More information: BIOTRONIK Home Monitoring About TRUST Trial Developed by a steering committee of electrophysiologists and cardiologists, with 1,443 patients enrolled from 105 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, fully wireless system that performs daily telemetric surveillance of the patient and the technical status of the implanted device, without requiring patient activation.

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