June 22, 2009 – BIOTRONIK GmbH today announced CE mark approval and first implantations of the new Evia cardiac pacemaker series, which features the only pacemaker with wireless, remote/home monitoring capabilities.
After receiving CE mark, the first Evia devices were successfully implanted simultaneously at seven hospitals across Europe during the first week of June. “Unique features such as closed loop stimulation and home monitoring, combined with new functions make Evia the most complete pacemaker available. I can now offer my patients a new level of therapy, and I have a streamlined patient management procedure from implantation to long-term monitoring, this bodes well for the future of bradycardia therapy,” said Dr. Philippe Ritter from the University Hospital in Bordeaux, France, and chairman of Cardiostim.
Combined with the BIOTRONIK Home Monitoring, Evia is the world’s first and only pacemaker series which wirelessly transmits all required patient and device data, including IEGM Online HD, to perform a complete remote follow-up. This technology is fully compliant with HRS/EHRA device follow-up specifications, and in line with this, the FDA recently approved BIOTRONIK Home Monitoring as the only remote monitoring system on the market that can replace conventional device interrogation during follow-ups. BIOTRONIK Home Monitoring allows physicians to remotely monitor their Evia patients’ clinical and device status from anywhere in the world. This technology has been proven to be reliable and safe, and has demonstrated the highest patient compliance in the industry, as minimal patient involvement is required to operate the system and the data transmission is fully automatic.
The system allows early detection of clinically relevant event data more quickly so physicians can make immediate therapy decisions. In this way, for example, atrial fibrillation events, which can be asymptomatic, are detected earlier. Additionally, the new intelligent “traffic-light” system allows for automatic patient classification aimed at significantly simplifying clinic workflow, the company said.
To help with ever increasing patient volumes and follow-up burden, new functions simplify complex programming and enable easier and faster follow-ups. Evia is the first BIOTRONIK pacemaker incorporating atrial and ventricular capture control, which automatically analyzes pacing thresholds and adjusts the amplitudes accordingly to assure reliable therapy and increased device longevity.
In addition to the new platform features, Evia builds on established and proven features such as the unique closed loop stimulation (CLS), which is the most advanced and physiological rate regulation algorithm available on the market. CLS integrates into the natural cardiovascular loop by measuring changes in myocardial contraction dynamics and translating them into appropriate heart rate regulation, emulating a healthy sinus node, the human heart’s natural pacemaker. CLS is the only rate regulation algorithm that initiates pacing faster and more effectively during periods of emotional or mental stress, providing better heart rate response and variability, which together improve hemodynamics and optimize cardiac output for increased quality of life.
Evia pacemakers are already designed to be MRI-conditional, and BIOTRONIK is planning to launch a new pacemaker-lead system that will be MRI-compatible under specific conditions during the first half of 2010.
For more information: www.biotronik.com