BIOTRONIK ProMRI Pacing Systems Gain European Approval

BIOTRONIK has received European approval of its new ProMRI Pacing Systems: the Evia pacemaker series and Safio Spacing leads that are compatible with Magnetic Resonance Imaging (MRI) under specific conditions. Pacemakers are usually considered a contraindication for MRI, as the strong magnetic field and radiofrequency waves can interfere with pacemaker functioning and can generate electric currents in the leads. Previously, Medtronic gained approval in Europe for its Surescan line of pacemakers which are MRI compatible. BIOTRONIK’s entire Evia pacemaker series, including two single chamber and two dual chamber devices, has now also been cleared for use in combination with MRI. To gain approval, they were vigorously tested in various combinations of device and lead positions and lengths, scanning time periods, and body positions in the MRI machines. BIOTRONIK also offers a Home Monitoring system which allows physicians to remotely monitor their Evia patients’ clinical and device status. Physicians are alerted if there are any clinically relevant changes in their patients’ condition or pacemaker status before or after the MRI procedure and have immediate access to all relevant data.
Press release: BIOTRONIK Gains European Approval for Complete Series of MRI-Conditional Pacemakers and Leads…