Medtronic Brings MRI-Friendly Neurostimulation Implants to Europe

Minneapolis, Minn.-based medical device company Medtronic Inc. has introduced its implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain, reportedly the first of its kind. They are designed for full-body magnetic resonance imaging (MRI) scans under specific conditions.

The neurostimulation systems are CE marked for use in MRIs. The systems that are appropriate for MRI use, equipped with Vectris SureScan MRI leads include: RestoreSensor SureScan MRI, PrimeAdvanced SureScan MRI, RestoreAdvanced SureScan MRI, and RestoreUltra SureScan MRI. The SureScan neurostimulation systems for the treatment of chronic pain are not approved by the U.S. Food and Drug Administration for use in the United States.

The neurostimulation implants are placed under a patient’s skin to deliver mild electrical impulses to the spinal cord, which act to block pain signals from going to the brain. According to Medtronic, patients feel a tingling sensation from the neurostimulation in areas where they had previously experienced pain.

“Neurostimulation therapy has become a mainstay of chronic pain management, and the introduction of full-body, MRI-compatible spinal cord stimulation systems is an important advancement that will help ensure neurostimulation patients have access to the diagnostic tools needed to quickly identify potentially critical health conditions,” said JP Van Buyten, M.D., from the AZ Niklaas Hospital in Belgium.

MRI scans allow physicians to make a wide range of health diagnoses by viewing highly detailed images of internal organs, blood vessels, muscle, joints, tumors, areas of infection and more. MRI uses strong magnetic fields and radio frequency pulses to create images of structures inside the body.

As advancements in technology have increased MRI accuracy, effectiveness and patient comfort, MRI use has increased dramatically in recent years. It is estimated that 60 million MRI procedures are performed worldwide each year. According to World Bank data, in Western Europe alone, 29 million scans were performed in 2010, with the number of scans doubling every five years.

Medtronic SureScan neurostimulation systems address a significant medical need for full-body MRI compatibility by enabling patients who are receiving Medtronic neurostimulation therapy for chronic back and/or leg pain (also called spinal cord stimulation, or SCS) to have access to the benefits of full-body MRI. Until now, SCS patients were denied full-body MRI scans for fear of the system being affected by the scanner’s large magnets.

“Delivering systems that are compatible with a full-body MRI scan means that spinal cord stimulation patients will not have to compromise when it comes to their healthcare, and they can feel secure knowing that MRI is a diagnostic option,” said Julie Foster, general manager and vice president of pain stimulation and targeted drug delivery in the Neuromodulation business of Medtronic. “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.”

Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or eliminate the hazards produced by the MRI environment. The devices also include a proprietary SureScan programming feature designed to set the device into an appropriate mode for the MRI environment.

These systems are the latest additions to a growing number of Medtronic devices that are safe for MRI access to any region of the body when used according to specified MR conditions for use.