Biotronik has announced that its newest pacemaker systems have been approved for European use in patients undergoing ultra-high field magnetic resonance imaging (MRI) scans.
Users of the single and dual-chamber pacemakers from the Edora, Evity and Enitra series of pacing devices are now able to undergo 3 tesla full-body scans without any restrictions on the scanned body area.
“Biotronik has received CE Mark approval for 3 tesla full-body scans to be performed using its newest MR-conditional pacemaker systems.“
The company was able to secure European CE Mark approval for this usage thanks to the application of its ProMRI technology, which makes it possible to conduct MRI scans without affecting the functionality of the pacemakers.
The ProMRI pacemaker portfolio was previously approved for 1.5 T scans. With 3 T compatibility, radiologists can offer scans of areas of the body that are not usually possible for pacemaker patients, including the breast, heart, abdomen and spine.
Manuel Ortega, senior vice-president at Biotronik, said: "We endeavour to break down barriers that prevent device patients from safely undergoing the MRI scanning they need. With 3 T FBS approval for our latest range of pacemakers, we're excited to enable patients to undergo ultra-high field MRIs without any area restrictions."
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