FDA approves Evia pacemaker for distribution in the U.S.

BIOTRONIK today announced that the U.S. Food and Drug Administration has cleared the Evia^® pacemaker for distribution in the U.S., giving physicians and patients access to a unique Bradycardia system designed and manufactured with BIOTRONIK's unparalleled legacy of quality.

“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”

Evia^® is the only device that provides a decade of longevity and innovative therapies for physiologic pacing packaged into a device that is 20 percent smaller than our current can size and which has integrated wireless remote monitoring. BIOTRONIK is a leading manufacturer of high-quality implantable cardiac devices and the pioneer of wireless remote monitoring technologies.

Setting the Standard for Remote Monitoring

Evia provides advanced patient management with the complete integration of the clinically proven BIOTRONIK Home Monitoring^® system. BIOTRONIK introduced home monitoring to the industry almost a decade ago with a system that today monitors, stores data, and provides physicians with early alerts that save lives and prevent hospitalizations. Evia has the unique capability to cellularly transmit required patient and device data, including IEGM Online HD, to perform a complete remote follow-up. It is the world's smallest pacemaker with integrated wireless remote monitoring. This technology is fully compliant with Heart Rhythm Society and European Heart Rhythm Association device follow-up specifications. Last year, the FDA approved BIOTRONIK Home Monitoring^® as the only remote monitoring system on the market that can replace conventional device interrogation during follow-ups.

Quality in every step of the production process

"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," commented Jake Langer, president, BIOTRONIK U.S.

Evia is the first pacemaker in which all electronic components have been manufactured and tested with full automation, eliminating human touch and minimizing room for human error.

"BIOTRONIK is committed to developing and delivering products like Evia, because quality of life is paramount for patients," Langer added.

Longevity - A new standard

The REPLACE Registry, sponsored by BIOTRONIK, is a multi-center analysis that quantified complication rates in device replacement procedures utilizing devices from all CRM industry manufacturers. The registry showed that one in 10 patients will suffer side effects and complications from device replacement.

"By providing a decade of longevity with Evia, BIOTRONIK again has demonstrated its focus on patient-centric innovations," stated Langer. "Evia's new design provides a dramatic reduction in energy consumption. Replacement is safe for most patients, but we have minimized that small risk to a new standard."

Small Device Delivers Wide Array of Therapy

Evia includes BIOTRONIK's proprietary and proven Closed Loop Stimulation (CLS), which is the most 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. CLS is also the only rate regulation algorithm that is proven 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.