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February 19, 2021

FDA approves expanded MRI labeling of Medtronic’s InterStim systems

The US Food and Drug Administration (FDA) has approved expanded MRI labelling of Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems, which use SureScan MRI leads.

The US F ood and Drug Administration (F DA) has approved expanded MRI labelling of Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems, which use SureScan MRI leads.

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With the help of a small device, SNM sends electrical impulses to the sacral nerves in the lower back for improving bladder and bowel control.

In contrast to oral medications, which target the muscular component of bladder control, SNM provides symptom control by directly modulating the nerve activity, normalising the communication between the bladder and the brain.

The latest development will enable a wider range of MRI scan parameters and reduced wait time between MRI scans, enhancing patient access to MRI exams and increasing flexibility for the providers.

It is applicable for existing and future implants of InterStim systems that use SureScan MRI leads.

F or MRI scanning facilities with B1+rms technology, the latest SureScan MRI lead scanning parameters increase B1+rms for 1.5 Tesla scans from 3.0µT to 4.0µT and 3 Tesla scans from 1.3µT to 2.0µT.

F urthermore, the revised scanning parameters increase SAR limits for 1.5 Tesla scans from 0.5W/kg to 2.0W/kg and for 3 Tesla scans from 0.5W/kg to 1.4W/kg.

It also cuts down the wait time from 60 minutes to five minutes for maximum duration scans (30 minutes).

The guideline updates are in addition to the benefit already provided by SureScan MRI technology that impedance checks before an MRI scan are not needed, offering increased efficiency in patient care compared to other SNM systems on the market.

Medtronic Restorative Therapies Group Pelvic Health & Gastric Therapies president Brooke Story said: “Our updated InterStim SureScan MRI labelling means the best choice in SNM therapy keeps getting better.

“We have had over 70 F DA approvals for the InterStim portfolio and are committed to continuing to innovate so we can help physicians bring life-enhancing technologies to more patients.”

Medtronic has also secured approval for its DiamondTemp Ablation (DTA) system from the F DA for treating patients with atrial fibrillation (AF ).

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  • A proprietary algorithm that leverages numerous pricing sources, with an emphasis on real-world data
  • Estimates of the likely spread of selling prices per brand and manufacturer, as well as 3-year forecasts for prices
  • Medical device pricing data that can be tracked by market, company, and brand
  • Additional categories that can be built on a custom basis
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