BIOTRONIK SE & Co. KG, a leading manufacturer of high-quality implantable cardiac devices and pioneer of wireless remote monitoring technologies, announced today the commercial availability of its new ProMRI® Pacing Systems — Evia pacemaker series and Safio pacing leads — providing European patients the first portfolio of bradycardia systems that are compatible with Magnetic Resonance Imaging (MRI) scans under specific conditions.
“We are very pleased to make this technology available to tens of thousands of European patients who now can confidently undergo MRI.”
During Cardiostim 2010, BIOTRONIK will officially launch its ProMRI® Pacing Systems, the only MRI-compatible portfolio of pacemakers and leads for the entire European market. Tomorrow BIOTRONIK will host a presentation on the science behind the ProMRI® Pacing Systems at its booth at the Nice Acropolis Convention Center.
ProMRI® for more access and more options
The BIOTRONIK ProMRI® series marks the first time an entire pacemaker portfolio, including two single chamber and two dual chamber devices, has been designed, tested and approved to make MRI scans possible for patients under certain conditions. As a result, physicians have the unique opportunity to select the optimal device from the Evia pacemaker series with the most advanced physiological therapy available and at the same time, give their patients access to MRI scanning.
Until recently, the two million European patients with implanted pacemakers were prohibited from receiving MRI scans, because the strong forces applied as part of the MRI scanning could negatively affect the pacemaker system or patients' safety.
"Evia is a ground-breaking pacemaker series, offering the most advanced therapy, remote monitoring and follow-up on the market," said Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. "We are very pleased to make this technology available to tens of thousands of European patients who now can confidently undergo MRI."
Unique and complete set of pacemaker features
In addition to MRI compatibility, the Evia pacemaker series includes unique innovations such as BIOTRONIK's proprietary and proven Closed Loop Stimulation® (CLS), which is the most advanced physiological rate regulation algorithm available on the market and is proven to adapt the pacing rate effectively even during periods of acute mental stress.
Evia also includes Vp Suppression® and IRSplus®, which minimize unnecessary ventricular pacing, in order to lower patients' risk of developing atrial fibrillation and heart failure. In addition to these innovations, Evia is the world's smallest, wireless remote monitoring pacemaker with industry-leading longevity beyond 13 years.
The Safio active fixation leads are the thinnest MRI-conditional pacing leads currently available on the market today, with a flexible distal end, fractal coating and steroid elution to ensure optimal electrical performance and a stable fixation.
Continuous assurance with remote patient monitoring before and after MRI scanning
Evia with ProMRI® provides advanced patient management with the complete integration of the clinically proven BIOTRONIK Home Monitoring® system. BIOTRONIK introduced home monitoring to the industry a decade ago with a system that today monitors, stores data and provides physicians with early alerts that help to prevent hospitalizations and is proven to reduce the time between event onset to patient evaluation by nearly a month compared to devices without remote monitoring.
BIOTRONIK Home Monitoring® is the only remote patient monitoring system on the market today that has FDA and CE approvals to safely replace conventional in-office device follow-ups and provide early detection of symptomatic and even asymptomatic clinical events. Before and after MRI scanning, BIOTRONIK Home Monitoring® allows physicians to remotely monitor their Evia patients' clinical and device status at any time, from anywhere in the world.