News | June 22, 2009

BIOTRONIK Introduces Only Pacemaker Platform With Integrated Wireless Remote Follow-up

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:

Related Content

Biotronik Announces U.S. Launch of Edora HF-T QP CRT Pacemaker
Technology | Cardiac Resynchronization Therapy Devices (CRT)| August 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and commercial availability of Edora HF-T QP, an...
The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Ohio State Researchers Prove Human Heart's 'Battery' Has Multiple Backups
News | EP Lab| July 27, 2017
July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural...
Wearable monitors create patient generated health data, PGHD, that can help prevent acute care episodes in heart failure.

Wearable monitoring devices may offer a new tool to help prevent acute care episodes in heart failure.

Feature | Heart Failure| July 25, 2017 | Lola Koktysh
Despite their best efforts, many patients tend to develop heart failure after an acute event (e.g., a heart attack or
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems| July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Overlay Init