Biotronik said today it won CE Mark approval in the European Union for 3 Tesla full-body scans with its latest range of MR conditional pacemakers featuring its ProMRI technology.
The new clearance covers single and dual chamber pacemakers from the Edora, Evity and Enitra series during ultra-high field MRI scans. The approval makes it possible to scan areas of the body typically off limits to pacemaker patients, Biotronik said.
“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. 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,” Dr. Matthias Schmitt of the University Hospital of South Manchester NHS Foundation Trust said in a prepared statement.
Biotronik said that it is also providing an online tool to allow physicians to prospectively or retrospectively check the MR conditions of any of its devices according to device model, lead types and country regulations.
“We endeavor 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,” senior VP Manuel Ortega said in a prepared release.
In May, Biotronik said it won FDA approval for its MultiPole Pacing technology designed for its cardiac resynchronization therapy defibrillator systems.