Biotronik, a manufacturer of implantable cardiac devices, has received European approval for ProMRI Pacing Systems Evia pacemaker series and Safio S pacing leads.
The approval provides European patients with a portfolio of bradycardia systems that are compatible with magnetic resonance imaging (MRI) scans under specific conditions.
Biotronik claimed that the approval of ProMRI series is the first time an entire pacemaker series, including two single chamber and two dual chamber devices, has been cleared for use in combination with MRI. In this way, physicians have the 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.
Biotronik’s ProMRI portfolio includes four different Evia pacemakers and two different lengths of the Safio S pacing leads.
The system was designed and approved for use with MRI under specific conditions. To gain approval, the new ProMRI Pacing Systems (Evia pacemakers with the Safio S leads) were tested in various combinations of device and lead positions and lengths, scanning time periods, and body positions in the MRI machines, all under strict regulation of the notified body.
The Evia pacemaker series combines MRI compatibility with innovations for advanced patient management, from the point of implant through follow-up. The small-sized pacemakers with extended longevity also provide several automatic functions to ensure a safe and convenient implantation procedure.
Biotronik also claimed that in addition to the new platform features, Evia builds on established and proven innovations such as Closed Loop Stimulation (CLS), which is the only rate regulation algorithm that provides appropriate heart rate response during periods of emotional stress, for improved hemodynamics and enhanced quality of life.
To meet individual patients’ needs, Evia also provides two algorithms, Vp Suppression and IRSplus, which minimize unnecessary ventricular pacing, in order to lower patients’ risk of developing atrial fibrillation and heart failure. With a thin lead body (6.6 F), Safio S are active fixation leads with a flexible distal end, fractal coating and steroid elution to ensure optimal electrical performance and a stable fixation.
Marlou Janssen, vice president of global marketing and sales, Cardiac Rhythm Management (CRM) at Biotronik, said: “We are pleased to offer physicians the choice to select from a series of the most technologically advanced pacemakers the Evia series of pacemakers and at the same time give their patients access to MRI diagnostic procedures.
“Biotronik is developing an entire CRM portfolio of MRI-compatible devices offering quality therapies to enhance patients’ safety and expand treatment options.”