Biotronik said yesterday it won CE Mark approval in the European Union for 2 next-generation MRI-safe pacemakers.
The new devices are compatible with up to 3 tesla MRI scanning machines, the company said. Around 20-30% of MRI machines worldwide are 3T machines, Biotronik said, and the number of these devices is growing.
“The benefits of 3 T MRI scanners are clear. 3 T scanners offer superior image quality, as well as a shorter scan time compared to a 1.5 T machine. Patients with ProMRI devices enabling 3 T scans benefit from a shorter time spent in the sometimes uncomfortable MRI machine, while doctors benefit from clearer images to diagnose conditions. Reduced scan times can improve clinical workflow, granting more patients access to this vital diagnostic tool,” Dr. Maurizio Lunati of Milan, Italy’s Niguarda Hospital said in prepared remarks.
Biotronik said the addition to its lineup makes it the 1st company to offer both 3T MRI-safe implantable cardioverter-defibrillators and pacemakers. With the release, the company also released a system, called ProMRI, which allows physicians to check if a patient’s devices are compatible.
“Along with the development of tools like the ProMRI system check website, our continued effort to gain MRI approval for all our devices and leads demonstrates Biotronik’s commitment to serving patients and physicians. As 3 T MRI scanners become more and more prevalent, it is essential that device patients are able to access them. Through innovation and diligence we have developed the world’s largest portfolio of ProMRI devices. We are pleased to expand our existing portfolio of approved ICDs and pacemakers by gaining CE approval for 3 T MRI scanning for the latest pacemaker generations,” senior veep Manuel Ortega said in a press release.