BIOTRONIK Patients Granted Access to Ultra High Field Magnetic Resonance Imaging

Implantable Defibrillators Gain CE Approval for 3.0 Tesla and Full-Body MRI Scans

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.

  1. 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.
  2. 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.
  3. Kalin and Stanton, Pacing and Clinical Electrophysiology (2005), 28: 326-328.
  4. Data on file.


At BIOTRONIK, patient well-being is our top priority and has been for 60 years. BIOTRONIK is a leading global medical technology company with products and services that save and improve the lives of millions suffering from heart and blood vessel diseases as well as chronic pain. Driven by a purpose to perfectly match technology with the human body, we are dedicated innovators who develop trusted cardiovascular, endovascular and neuromodulation solutions. BIOTRONIK is headquartered in Berlin, Germany, and is represented in over 100 countries.