ProMRI® is a new technology from BIOTRONIK which allows patients with a cardiac device system (pacemaker or defibrillator and implantable cardiac monitor) to safely undergo MRI examinations under certain conditions. ProMRI® devices from BIOTRONIK include the latest innovations to provide you with the most up-to-date device therapy – plus the opportunity for improved diagnostics via MRI scanning.
Until recently, patients with an implantable cardiac device weren’t able to undergo MRI scanning because the strong magnetic fields present during the procedure could harm the cardiac device and the leads connecting the device to the heart. However, patients with implantable cardiac devices often need MRI scans, and MRI scans are preferrable to other forms of diagnostic imaging because they’re the best way to create very detailed pictures of internal organs and structures. An additional benefits is that they don’t expose patients to radiation.
BIOTRONIK's ProMRI® systems have been rigorously tested and are approved for use during an MRI procedure. So, with BIOTRONIK's special ProMRI® devices and leads, patients can safely undergo certain MRI procedures.
The first European pacemaker to be approved for safe use in certain MRI procedures was available in November, 2008. The first MR imaging within a human body was successfully performed on April 10th, 2007 in the University Hospital of Zurich, Switzerland. Today there are more pacemakers available for specific MRI uses. They all use similar technology and have similar restrictions.
BIOTRONIK pacemakers with ProMRI® technology have been available since June 2010. Since April, 2012 BIOTRONIK has been the only company worldwide to offer ProMRI® ICD and CRT systems. Since October, 2013 BIOTRONIK has also offered implantable cardiac monitors with ProMRI® technology.
BIOTRONIK offers systems with ProMRI® throughout its implantable cardiac device portfolio. This includes single-chamber, dual-chamber and triple-chamber pacemakers, defibrillators and implantable cardiac monitors. To find out if your system features the new ProMRI® technology, check your pacemaker or defibrillator ID card to see whether there is a checkmark in the box “MR scan.”
No, ProMRI® does not create any additional risks. ProMRI® is a special product feature designed to enable patients with a cardiac device to undergo MRI scanning. The device and leads have been designed with components which do not interfere with the strong magnets and radiofrequency fields within the scanner. The actual pacemaker, ICD or CRT and implantable cardiac monitor functionality have not been changed; ProMRI® is an additional function.
The ProMRI® feature of BIOTRONIK cardiac devices has been rigorously tested. In order to ensure these devices’ safety in an MR environment, tests were designed to exceed the normal limits of stipulated by regulatory agencies and safety guidelines established by the European Cardiology Society (ECS) and others. Furthermore, an independent authority has examined the product design and strictly observed the MRI tests before giving approval for this specific use of the device. Pacemaker patients have already been able to undergo MRI procedures for several years and there has never been an issue with any patient during an MRI scan.
There is no difference in the treatment of your condition when you have a cardiac device with ProMRI®. Your physician will continue to schedule your regular in-clinic follow-ups, or monitor your condition remotely with BIOTRONIK Home Monitoring®.
In the future, if you are referred for an MRI scan appointment, you should mention that you have a ProMRI® cardiac device implanted. Your pacemaker, ICD or CRT needs to be programmed into another pacing mode before the MRI scan. After the MRI scan, it will be reprogrammed to the initial setting.
Please make sure you have your cardiac device identification card with you when you go for an MRI scan.
Implantable cardiac devices and leads with ProMRI® are specifically designed to meet the requirements for a safe MRI scan under certain conditions. ProMRI® is designed only for this very specific purpose, and does not protect against any potential interference from other electrical devices or equipment. For information about electrical device interference with cardiac implants in general, please refer to the pacemaker patient brochure found here.
Since ProMRI® is a recent innovation, most cardiac device patients do not have the advantage a ProMRI® system implant offers. This means you will need to be proactive and make your doctor aware that you are able to undergo an MRI scan because of your special ProMRI® system. When scheduling an MRI scan, you should mention that you have a ProMRI® system implanted. It is also useful to have your pacemaker identification card with you for the scan—and at all times. The card indicates that your cardiac device system is compatible with MRI scans.