BIOTRONIK Launches Evia Pacemaker Series.

First and only pacemaker approved for wireless patient monitoring & remote follow-up

BERLIN -- BIOTRONIK SE & Co. KG, the pioneer of wireless remote monitoring technologies and leading manufacturer of implantable cardiac devices, today announced the European launch of its new, unified platform pacemaker series, Evia, and several new products to further strengthen its bradycardia portfolio.

New Bradycardia portfolio BIOTRONIK continues its product innovation stream with the launch of a completely new bradycardia product portfolio, including the Evia pacemaker series, the new Siello pacing leads as well as a new external pacemaker, Reocor, and a new pacing system analyzer, Reliaty.

Evia - Wireless patient monitoring & remote follow-up Evia is the first and only pacemaker with complete, wireless remote monitoring and follow-up capabilities. Patients with an Evia pacemaker can be remotely monitored through the proven BIOTRONIK Home Monitoring([R]) wireless system with only one annual in-clinic visit. BIOTRONIK Home Monitoring([R]) technology has been approved to safely and effectively replace conventional in-clinic device follow-up visits. Evia and BIOTRONIK Home Monitoring([R]) open new ways to efficiently care for and manage the increasing number of patients with pacemakers. Now physicians have the choice to call in their patients to the clinic or perform remote follow-ups with complete access to all pertinent patient and device information, including high quality IEGM Online HD([R]). Importantly, BIOTRONIK Home Monitoring([R])has also received FDA and CE Mark approval for its early detection monitoring technology which allows clinicians to access their patients' clinically relevant event data more quickly so they can make immediate therapy decisions to improve patient care.

Evia - A complete pacemaker system Evia incorporates unique innovations for every step of advanced patient management from implant to follow-up. The small-sized pacemakers with extended longevities also provide several automatic functions to ensure a safe and convenient implantation procedure. In addition to the new platform features, Evia builds on established and proven innovations such as the unique Closed Loop Stimulation([R]) (CLS), which is the most advanced and physiological rate regulation algorithm available on the market today. CLS is the only rate regulation algorithm that provides appropriate heart rate response, during periods of emotional stress, for improved hemodynamics and increased quality of life.

To meet individual patients' needs, Evia also provides two new algorithms, Vp Suppression([R]) and IRS(plus[R]). These new Evia features are designed to reduce unnecessary ventricular pacing to a minimum, in order to lower patients' risk of developing atrial fibrillation and heart failure.

Siello Pacing Leads - Quality design for complete reliability The new Siello pacing leads have been designed by BIOTRONIK to ensure long-lasting reliability and patient safety. The ultra-thin lead body (5.6 French) with a new polyurethane coating enables more successful implantation especially in patients with smaller vessels and a more complex anatomy.

New technology platform to include MRI-conditional systems 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 has been engineered with significant technological advancements, resulting in small sized devices and significantly extended longevities. This is another example of BIOTRONIK's commitment to develop the highest quality and the most complete bradycardia product portfolio," stated Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. "The Evia pacemaker in combination with BIOTRONIK Home Monitoring([R]) is the Industry's first and only pacemaker with approved wireless remote patient monitoring capabilities and this represent significant enhancements in the treatment and care of bradycardia patients."

About BIOTRONIK Home Monitoring([R] ) BIOTRONIK was first to develop and introduce, an internet-based, wireless remote monitoring system using the GSM telephone network. Today, more than 230,000 BIOTRONIK Home Monitoring([R]) systems have been implanted, in more than 55 countries worldwide helping to optimize patient care. BIOTRONIK Home Monitoring([R]) is available across the entire BIOTRONIK product portfolio of pacemakers, ICD and CRT devices enabling remote device follow up at any time from anywhere in the world.

BIOTRONIK's Home Monitoring technology has been nominated for the prestigious German Federal President's "Deutscher Zukunftspreis" (German Innovation Award) for its pioneering achievement in medical technology.

More information: BIOTRONIK Home Monitoring

About BIOTRONIK SE & Co. KG As one of the world's leading manufacturers of cardiovascular medical devices, with several million devices implanted, BIOTRONIK is represented in over 100 countries by its global workforce of 4,900 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.

More information: www.biotronik.com

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