Medtronic, a medical device manufacturer based in Minneapolis, Minnesota, announced that its pain management implants with neurostimulation technology are the first in class to receive CE Mark approval in the European Union for use during full-body MRI scans.
According to a press release by the company, Medtronic’s neurostim devices use a mild electrical pulse to block pain signals as they travel to the brain. Since pain management patients often require diagnostic imaging, traditional neurostimulation implants aren’t a viable option.
Medtronic’s new neurostim devices include a specialized programming option that includes a “safe mode” for use in MRI environments. This makes the device safe to use in the presence of high-intensity magnetic fields. In addition, the company’s neurostimulation implants feature durable leads that can withstand MRI-grade magnetic fields.
Julie Foster is a vice president and general manager at Medtronic. In prepared remarks, she said, "Medtronic's development of these systems is another example of our commitment to advancing increasingly innovative and cost effective solutions that make it easier for clinicians to safely, effectively and efficiently diagnose and treat the patients they serve."
According to health regulators in the European Union, Medtronic’s RestoreAdvanced SureScan MRI implant, the RestoreSensor SureScan MRI implant, the RestoreUltra SureScan MRI implant and the PrimeAdvanced SureScan MRI implant have been cleared for use with MRI machines.
In October of last year, the company introduced the Advisa MRI SureScan in Japan.