BERLIN, Germany, May 22, 2014 – BIOTRONIK, a leading manufacturer of cardiovascular medical technology that offers the world’s largest portfolio of ProMRI® cardiac implants, announced CE approval today of 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.BIOTRONIK is the first company worldwide to gain 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 and making the results all the more useful. Single-chamber and DX implantable defibrillators (ICDs) with atrial diagnostics are now approved with backwards compatibility for ultra high field 3.0 T scans with an exclusion zone.1
Having undergone extensive research and development, BIOTRONIK ICDs that have already been implanted are now approved for use with MRIs.
- 3.0 T scans are approved for Ilesto, Iforia, and Idova single-chamber and DX ICDs with LinoxSmart and Protego ProMRI® leads 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 LinoxSmart ProMRI® leads.
- Kalin and Stanton, Pacing and Clinical Electrophysiology (2005), 28: 326-328.
- Data on file.