Biotronik Receives CE Mark for 3 Tesla Full-Body MRIs With Newest Pacemakers

Biotronik SE & Co. Kg has received CE Mark approval for 3 tesla (T) full-body scans (FBS) with its latest range of magnetic resonance (MR) conditional pacemaker systems. Patients implanted with single- and dual-chamber pacemakers from the Edora/Evity/Enitra series can now benefit from ultra-high field magnetic resonance imaging (MRI) scans without any restrictions on the scanned body area.
 
Biotronik’s ProMRI pacemaker portfolio was previously approved for 1.5 T FBS. With 3 T FBS compatibility, radiologists can offer pacemaker patients additional high-quality imaging options. Approval for full-body scanning with 3 T makes it is possible to scan areas of the body that are typically off limits for pacemaker patients, including the breast, heart, abdomen and spine.
 
“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,” said Dr. Matthias Schmitt, University Hospital of South Manchester NHS Foundation Trust, United Kingdom. “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.”
 
In addition to benefitting from cardiac imaging, pacemaker patients are able to undergo ultra-high field MRIs for a variety of comorbidities, such as cancers or neurological disorders that require in-depth tissue examination. Three-tesla MRI is often the preferred modality for brain imaging, for example, in cases of multiple sclerosis, brain tumors and complex vascular brain imaging.
 
“We endeavor to break down barriers that prevent device patients from safely undergoing the MRI scanning they need,” said Manuel Ortega, senior vice president at Biotronik. “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.”
 
To complement the ProMRI cardiac device range, Biotronik’s online tool ProMRIcheck.com allows physicians to prospectively or retrospectively check the MR conditions of any Biotronik device system according to device model, lead types and individual country regulations.

Biotronik is based in Berlin, Germany, and has a global workforce of more than 5,600 employees. Its U.S. headquarters is located in Lake Oswego, Ore.