Medtronic receives FDA approval for expanded MRI labelling of InterStim SureScan MRI leads

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Medtronic has received approval from the US Food and Drug Administration (FDA) for expanded magnetic resonance imaging (MRI) InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads. 

Medtronic report that SNM uses a small device to send electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control

According to a company press release, the updated MRI Guidelines allow for a wider range of MRI scan parameters and shorter wait time between MRI scans, thereby improving patient access to MRI exams and adding flexibility for MRI providers. It applies to existing and future implants of InterStim systems that use SureScan MRI leads.

“I am pleased to see medical technology for SNM patients continue to improve,” said Howard Goldman, professor and vice chairman of Quality and Patient Safety, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, USA. “Optimal MRI labelling is an important enabler of greater access to therapy for patients and alleviates burdens on clinicians’ practices.”

According to Medtronic, these guideline updates are in addition to the benefit already provided by SureScan MRI technology that impedance checks prior to an MRI scan are not required, providing more efficiency in patient care versus the other SNM system on the market.

“Our updated InterStim SureScan MRI labelling means the best choice in SNM therapy keeps getting better,” said Brooke Story, president, Pelvic Health & Gastric Therapies, which is reported as part of the Restorative Therapies Group at Medtronic. “We have had over 70 FDA approvals for the InterStim portfolio and are committed to continuing to innovate so we can help physicians bring life-enhancing technologies to more patients.”


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