Neurostimulation from Medtronic receives CE mark for use with full-body MRI scans

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Medtronic has introduced in Europe their first implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions.

The first new system implants have been performed by JP Van Buyten and Iris Smet in

Belgium; Rasche and Tronnier in Germany; J De Andres in Spain; K Gatzinsky in Sweden, and Buchser in Switzerland.

Medtronic neurostimulation systems for the treatment of chronic pain recently received CE mark approval for compatibility with full-body MRI scans. Neurostimulation systems enhanced with this technology and using VectrisTM SureScan MRI leads include: RestoreSensor SureScan MRI, Prime Advanced 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 (FDA) for use in the USA.

“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, AZ Niklaas Hospital, Belgium.”

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 (spinal cord stimulation) to have access to the benefits of full-body MRI. Until now, spinal cord stimulation patients were denied full-body MRI scans because of fears of 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.

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, which sets the device into an appropriate mode for the MRI environment.

These systems are the latest additions to a growing number of Medtronic devices which are safe for MRI access to any region of the body when used according to specified MR Conditions for Use, including the Medtronic SynchroMed II programmable drug infusion system and the Advisa DR MRI SureScan pacing system available outside the US In the US, such devices include the Medtronic SynchroMed II programmable drug infusion system and the Revo MRI SureScan pacing system which are safe for MRI access to any region of the body when positioning guidelines are followed.

About Medtronic Neurostimulation Therapy for Chronic Pain

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

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