The US Food and Drug Administration (FDA) has approved Medtronic’s Specify SureScan MRI surgical leads, which are indicated for use as part of Medtronic implanted neurostimulation systems for chronic pain.
According to a company release, physicians can now offer a Medtronic full-body MR (magnetic resonance) conditional SCS (spinal cord stimulation) system best suited for their patients regardless of the type of neurostimulator (rechargeable or non-rechargeable) or lead type (percutaneous or surgical).
“All patients with a spinal cord stimulation system should have the ability to be offered the same imaging options as those without one,” says Steven Falowski, neurosurgeon at St. Luke’s University Health Network in Bethlehem, Pennsylvania. “Now more than ever, patients and other health care providers are concerned about access to MRI when considering an implantable device. This approval means I can offer a neurostimulation system that helps manage my patients’ pain and gives them access to the diagnostic benefits of MRI.”
The Medtronic release also lists the following as additional benefits of the Medtronic spinal cord stimulation therapy:
- The opportunity for patients to “test drive” spinal cord stimulation with an external stimulator for a 3 to 10 day trial period.
- AdaptiveStim technology, which adjusts stimulation automatically.
- Personalisation to empowers patients to manage their own pain therapy by adjusting their stimulation within pre-set limits.