German cardiac device-maker Biotronik announced that 2 studies have confirmed its ProMRI pacemaker systems are safe to use with certain MRI procedures.
The studies tracked 226 patients with ProMRI Evia/Entovis SR-T and DR-T pacemaker systems for up to 1 month after they received MRI scans of either the head or lower lumbar region. Neither study reported any serious adverse events.
Results from the studies were published in the current issue of the medical journal Heart Rhythm.
“The results confirm the safety and reliability of Biotronik’s ProMRI devices in clinical practice,” said Dr. William M. Bailey, the study’s author, in a statement. “MRIs are now a fairly common diagnostic tool and the likelihood that cardiac implantable electronic device (CIED) patients will require one at some point increases with the aging population. ProMRI devices are therefore the obvious choice for physicians and patients alike.”
“The results of these studies are consistent with the extensive testing and simulation of these devices as part of the data collected to receive CE approval,” said Biotronik Vice President Wolf Ruhnke, in a statement. “With our investment in ProMRI technology and the body of evidence to prove its safety, physicians can confidently decide to perform a needed MRI scan on these patients. We believe that in the future, no cardiac device patient will be hindered from receiving this valuable diagnostic tool.”
Last fall, Biotronik paid $5 million to settle U.S. federal allegations that it used kickbacks to induce doctors to use its cardiac rhythm-management devices.