Biotronik, a manufacturer of implantable cardiac devices and the provider of wireless remote monitoring technologies, has received FDA clearance for its Evia pacemaker for distribution in the US.
Biotronik Evia is the device that provides therapies for physiologic pacing packaged into a device that is 20% smaller than current can size and which has integrated wireless remote monitoring. Evia provides patient management with the integration of the clinically proven Biotronik Home Monitoring system.
Biotronik claimed that Evia has the capability to cellularly transmit required patient and device data, including IEGM Online HD, to perform a complete remote follow-up. It is the smallest pacemaker with integrated wireless remote monitoring. The technology is fully compliant with Heart Rhythm Society and European Heart Rhythm Association device follow-up specifications.
Evia includes Biotronik’s Closed Loop Stimulation (CLS), which is the advanced and physiologic 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.
Jake Langer, president of Biotronik US, said: “Biotronik looks forward to providing physicians with the important advancements Evia will bring to their practices. Evia is the latest example of Biotronik’s absolute commitment to deliver quality products designed to enhance patients’ lives. Biotronik is committed to developing and delivering products like Evia, because quality of life is paramount for patients.”