First and only pacemaker platform with fully integrated wireless remote follow-up capabilities introduced at Europace congress in Berlin

Evia - the new technologically advanced pacemaker series from BIOTRONIK - receives European CE approval

(PresseBox) (Berlin, ) BIOTRONIK GmbH & Co. KG, the pioneer of wireless remote monitoring technologies and leading manufacturer of implantable cardiac devices, today announced CE Mark approval and first implantations of the new Evia cardiac pacemaker series, offering superior therapies and functionality in every step of advanced patient management.

Successful first implants across Europe

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, after the first implantation in Bordeaux on June 4.

World's first and only pacemaker with completely wireless remote monitoring capabilities

Combined with the clinically proven1 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.

Importantly, the early detection function of BIOTRONIK Home Monitoring® allows clinicians to access their patients' clinically relevant event data more quickly so they 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.

Evia - A complete pacemaker system

Optimal and efficient clinic workflows are being challenged by an ever increasing patient and follow-up burden. Therefore, new functions which simplify complex programming and enable easier and faster follow-ups become increasingly important. Offering a complete solution for advanced patient management, Evia provides physicians with the most physiological therapy available, as well as enhanced functions for fast and efficient implantations, accelerated follow-ups and reliable long-term monitoring of patients. The new Evia system now permits physicians to streamline the initial device set-up process and access all necessary data required during follow-up without spending valuable time on interrogating the device.

Advanced features for the most physiologic therapy

There is strong clinical evidence that unnecessary ventricular pacing worsens patients' cardiac condition. The new Evia Vp Suppression® algorithm is designed to reduce unnecessary ventricular pacing to a minimum, thereby decreasing the risks associated with high incidence of ventricular pacing. 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.

New technology platform to include MRI-conditional devices

Evia is the first pacemaker series based on a completely new, innovative technology platform. Evia pacemakers are already designed to be MRI-conditional, and BIOTRONIK is planning to launch a new pacemaker-lead system which will be MRI-compatible under specific conditions during the first half of 2010. "The new Evia platform which has been innovatively engineered to significantly reduce energy consumption, resulting in small sized devices and longevities of up to 13 years, is another example of BIOTRONIK's commitment to develop the highest quality and the most technologically advanced bradycardia product portfolio," commented Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. "In combination with the unique BIOTRONIK Home Monitoring technologies, the new Evia pacemaker series further strengthens our position as the leader in wireless remote patient management."

Acknowledgment

BIOTRONIK would like to extend its sincere thanks to the physicians who participated in
the world’s first implantations of the Evia pacemaker series:
Dr. Johan Brandt, Lund University Hospital, Lund, Sweden
Dr. Steffen Löscher, Klinikum St. Georg, Leipzig, Germany
Dr. Thomas Melchior, Roskilde Sygehus, Roskilde, Denmark
Dr. Michael Nürnberg, Wilhelminenspital Wien, Vienna, Austria
Dr. Philippe Ritter, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
Dr. Martin Schalij, University Medical Center Leiden, Leiden, The Netherlands
Dr. Jorge Silvestre, Hospital Universitario La Paz, Madrid, Spain

References

1. N. Varma et al. Evaluation of efficacy and safety of remote monitoring for ICD followup:
the TRUST trial. Circulation 2008;118;2309-2317, Abstract 4078.

BIOTRONIK

As one of the world's leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is represented in over 100 countries with its global workforce of more than 4500 employees. Known for having its finger on the pulse of the medical community, BIOTRONIK assesses the challenges physicians face, and provides the best solutions for all phases of patient care, ranging from diagnosis to treatment to patient management. Quality, innovation and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

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