Interventional device developer Medtronic has begun shipments of a neurostimulation implant that can be used in MRI scans of patients who meet certain conditions.
The company's RestoreSensor SureScan neurostimulation device is designed to be implanted for spinal cord stimulation for the treatment of chronic, intractable back and/or limb pain.
Patients with spinal cord stimulation implants who are referred for body MRI scans are often rejected for imaging due to concerns about the effect of the scanner's magnetic fields on the devices. But Medtronic's neurostimulation systems with SureScan MRI technology and Vectris SureScan MRI percutaneous leads are designed with enhancements to reduce or eliminate the hazards produced by the MRI environment, according to the company.
The products also include a feature that sets the neurostimulator into an appropriate mode for the MRI suite, enabling radiology personnel to confirm that a patient's implantable system is safe for MRI scanning.
The RestoreSensor SureScan system is one of a portfolio of new Medtronic neurostimulation systems that are enhanced with the new technology and that use Vectris SureScan MRI leads. Other products include PrimeAdvanced SureScan MRI, RestoreAdvanced SureScan MRI, and RestoreUltra SureScan MRI.
The devices received U.S. Food and Drug Administration (FDA) approval in March 2013 and CE Mark approval in January 2013.
