Neurostimulation Systems Earn CE Marking for Use with Full-Body MRI Scans

The systems were recently introduced in Europe.

Medtronic, Inc.’s (Minneapolis, MN, USA) neurostimulation systems for the treatment of chronic pain recently received Conformité Européenne (CE) Marking approval for compatibility with full-body MRI scans. Neurostimulation systems enhanced with this technology and using Vectris SureScan MRI leads include: RestoreSensor SureScan MRI, PrimeAdvanced SureScan MRI, RestoreAdvanced SureScan MRI, and RestoreUltra SureScan MRI. Medtronic SureScan neurostimulation systems for the treatment of chronic pain are not approved by the US Food and Drug Administration for use in the United States.

“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 Dr. JP Van Buyten from the AZ Niklaas Hospital (Sint-Niklaas, Belgium).

As recent technologic development have increased MRI effectiveness and patient comfort, MRI use has increased dramatically in recent years. It is estimated that 60 million MRI scans are performed worldwide yearly. In Western Europe alone, 29 million scans were performed in 2010, with the number of scans doubling every five years.

Medtronic SureScan neurostimulation systems fulfill a vital 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 [SCS]) to have access to the advantages of full-body MRI. SCS patients, up to now, were denied full-body MRI scans because of worries that the system being affected by the large magnets involved in MRI.

“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, pain stimulation and targeted drug delivery in the neuromodulation business of Medtronic, Inc. “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 dangers generated by the MRI setting. The devices also include a proprietary SureScan programming feature, which sets the device into a suitable mode for the MRI environment.

Medtronic neurostimulation therapy for chronic pain uses a medical device positioned 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. Patients feel a tingling sensation from the neurostimulation Instead of pain in areas where they had earlier experienced pain.

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