BIOTRONIK won European regulatory approval allowing its Edora, Evity, and Enitra series of pacemakers to be safe for 3 Tesla full body scans, as long as certain precautionary measures are taken. This approval will allow more patients to take advantage of the high quality imaging that the more powerful MRI scanners offer, as previously these implants had MR-conditional approval up to only 1.5 Tesla. Full body scanning, on the other hand, opens up scanning of the chest, heart, and other organs close to the pacemaker and its leads.
Since these are existing pacemakers and it’s getting a bit confusing which are cleared for which scanner strengths, BIOTRONIK has setup a website (ProMRIcheck.com) to help cardiologists and radiologists quickly get the official word.
“As 3 T MRI becomes increasingly prevalent in the management of a variety of diseases, it is vital that pacemaker patients also have access to this invaluable mode of imaging,” in a published statement said Dr. Matthias Schmitt, University Hospital of South Manchester NHS Foundation Trust, UK. “Thoracic imaging at higher field strengths has improved significantly in recent years, allowing 3 T MRI to take on a significant role in cardiac imaging for events such as cardiac perfusion, cardiac toxicity and myocardial infarction, where visualization is key in guiding clinical decision-making. With more options for cardiac imaging, we can strive to improve care for patients with pacemakers.”