Biotronik single- and dual-chamber pacemakers and ICDs approved for use in 3 Tesla MRI scans worldwide


Biotronik has announced CE mark approval of 3 Tesla (T) magnetic resonance imaging (MRI) scanning with exclusion zone for its two latest generations of pacemakers*. A press release states that the company is now the only one offering both implantable cardioverter-defibrillators (ICDs) and pacemakers approved for 3T scans.

Roughly 20–30% of all MRI scanners installed worldwide are 3T. However, sales of these scanners are growing three times faster than sales of 1.5T scanners.

“The benefits of 3T MRI scanners are clear,” comments Maurizio Lunati, Niguarda Hospital, Milan, Italy. “These scanners offer superior image quality, as well as a shorter scan time compared to a 1.5T machine. Patients with ProMRI devices enabling 3T scans benefit from a shorter time spent in the sometimes uncomfortable MRI machine, while doctors benefit from clearer images to diagnose conditions. Reduced scan times can improve clinical workflow, granting more patients access to this vital diagnostic tool.”

To help physicians keep track of which ProMRI devices and leads are approved in their own region, new functions have been added to the ProMRI Systems Check website ( ProMRI Systems Check allows physicians to verify whether a patient’s individual device and lead combination is MR conditional, and under which scanning conditions. It is now available in five languages: English, French, German, Italian and Spanish.

* For all regions in line with CE regulations, all single- and dual-chamber ProMRI models of Eluna 8, Epyra 8/6 Etrinsa 8/6 and Evia, Entovis, Estella, Ecuro are now approved for 3T MRI scanning with an exclusion zone. All Setrox, Solia, Siello and Safio leads in combination with these devices, are approved for 3T MRI scanning under certain conditions. The dual-chamber system of Siello/Solia JT 45 is also 3T approved.