Biotronik gets CE mark approval for last two generations of ProMRI CRT-Ds


Biotronik has announced CE mark approval for its last two generations of ProMRI cardiac resynchronisation therapy defibrillator (CRT-Ds) systems. The approval allows full-body MRI scanning.

Biotronik now offers CRT-D patients access to full-body MRI scans, the gold standard in soft tissue imaging. Since 2013, it has had CRT-Ds approved for MRI scanning with an exclusion zone, now expanded to give these patients access to full-body MRI scanning at 1.5 tesla strength.

The devices approved for full-body 1.5 T MR imaging are: Inventra 7 HF-T, Iperia 7 HF-T, Iperia 5 HF-T, Itrevia 7 HF-T, Itrevia 5 HF-T, Idova 7 HF-T, Iforia 7 HF-T, Iforia 5 HF-T, Ilesto 7 HF-T and Ilesto 5 HF-T.

“This is a great development, especially in the treatment of heart failure patients, and opens diagnostic capabilities these patients were previously denied,” comments Albert C van Rossum from VU University Medical Center, Amsterdam, The Netherlands. “CRT-Ds are commonly implanted in patients with severe heart problems, often the result of a heart attack.

For the first time, we now have the opportunity to use the unique benefits of MRI to examine in depth how the heart reacts to resynchronisation therapy and adjust treatments if needed. Full-body MRI including the heart during resynchronisation therapy will give these patients a huge advantage, as it provides physicians much more detailed insight of their complex heart condition.”

Heart failure patients often have comorbidities such as stroke, which is best diagnosed through an MRI. “In Europe alone, heart failure affects at least 15 million people. It is a huge patient population and the chances of them needing a device or an MRI, or both, are high. That is why we make patient access to MRI scanning one of our top priorities,” says Manuel Ortega, senior vice president of Biotronik. “With CE approval of our last two generations of ProMRI CRT-Ds for full-body scanning, we broaden the options for physicians and patients, enabling optimal treatment.”