Biotronik’s defibrillators for 3.0 Tesla and full-body MRI get CE mark approval


Biotronik has announced receiving CE mark approval for its ProMRI technology for ultra high field 3.0 tesla (T) and full-body magnetic resonance imaging (MRI) with the standard 1.5 T scan strength.

The company states that it is the first one gaining CE approval for patients with cardiac devices to undergo 3.0 T MRI scans, enabling physicians to receive higher image quality scans more quickly, thereby lessening examination time for patients.

Single-chamber and DX implantable defibrillators (ICDs) with atrial diagnostics-including: Ilesto, Iforia, and Idova single-chamber and DX ICDs with Linox and Protego ProMRI leads- are now approved with backwards compatibility for ultra high field 3.0 T scans with an exclusion zone.

Full-body 1.5 T scans are available with Ilesto and Iforia single-chamber, dual-chamber and DX ICDs with Safio S and Linox ProMRI leads.

“Approval for full-body and higher resolution scans offers my ICD patients unparalleled access to potentially life-saving imaging. I often treat cardiac patients with comorbidities who would benefit from MRI diagnostic capabilities,” says Antonio Curnis, Spedali Civili Hospital, Brescia, Italy. “Now I can be confident in the safety of MRI scans for these patients.

Until recently, patients with a pacemaker or ICD were denied MRI scans due to the strong magnetic fields and radio waves that could negatively influence the devices. While 1.5 T machines remain the clinical standard, 3.0 T MRI scanners improve image quality and reduce scan time. Higher definition MRI scans help physicians see intricate details in soft tissue, for example in the brain. Shorter scan times are helpful for patients who experience claustrophobia or have difficulty holding still, such as young children or adults with dementia. The clinical use of 3.0 T is increasing worldwide,further underscoring the importance of MRI scans.

“As a radiologist, it is my job to make sure patients are given access to the best diagnostics to help treat their comorbidities,” says Philippe Cart, Manchester Hospital, Charleville-Mézières, France. “Increased options for Biotronik ICD patients mean that, depending on the clinical indication, patients may safely undergo the scan they need.”