BIOTRONIK Receives CE Mark for 3 Tesla Full-Body MRIs with Newest Pacemakers

Tuesday, June 13, 2017

Edora/Evity/Enitra Pacemaker Series Gives Patients Access to Ultra-High Field MRIs without Scanning Area Restrictions


BERLIN, Germany, June 13, 2017BIOTRONIK received CE approval for 3 tesla (T) full-body scans (FBS) with its latest range of 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 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, 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."

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," stated 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 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.


A global leader in cardio- and endovascular medical technology, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries. Several million patients have received BIOTRONIK implants designed to save and improve the quality of their lives, or have been treated with BIOTRONIK coronary and peripheral vascular intervention products. Since its development of the first German pacemaker in 1963, BIOTRONIK has engineered many innovations, including Magmaris, the first clinically-proven resorbable magnesium scaffold; BIOTRONIK Home Monitoring®; Pulsar, the world’s first 4 F compatible stent for treating long lesions; Orsiro, the industry’s first hybrid drug-eluting stent; and the world’s first implantable cardioverter defibrillators and heart failure therapy devices with ProMRI® technology.

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