FDA Clears Wireless, Remotely Monitored Pacemaker


May 13, 2010

May 13, 2010 – The U.S. Food and Drug Administration (FDA) has cleared a small pacemaker with integrated, wireless, remote monitoring capabilities. The Evia pacemaker is 20 percent smaller than previously released Biotronik pacemakers.

Evia allows for easier patient management with complete integration into the Biotronik Home Monitoring system. The system monitors, stores data, and provides physicians with early alerts of cardiac events. Using the system, device data can be transmitted via cellular networks to perform a complete remote follow-up.

The company said the pacemaker components are designed for full automation, eliminating human touch and minimizing room for human error.

Evia includes Biotronik’s proprietary closed loop stimulation (CLS), a physiologic rate regulation algorithm. 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 also provides a regulation algorithm to pace effectively during periods of acute mental stress. Intrinsic optimization (I-Opt), a one-button programming solution, optimizes AV delay with AV hysteresis (up to 400 ms) to minimize right ventricular pacing.

For more information: www.biotronik.com