FDA approves expanded labeling for sacral neuromodulation systems with SureScan MRI leads

The FDA approved expanded labeling for Medtronic’s InterStim II and InterStim Micro sacral neuromodulation systems that use SureScan MRI leads, enabling a broader range of MRI scan parameters, according to a press release from the company.

The approval, which applies to current and future implants of InterStim systems that use SureScan MRI leads, will also decrease wait times between scans, according to the release, which will increase flexibility for MRI providers.

The updated MRI labeling will offer patients and clinicians more options than other sacral neuromodulation systems that are currently available, according to the release.

In facilities with B1+rms technology, the “gold standard in MRI scanning technology,” the SureScan MRI lead scanning parameters increases B1+rms for 1.5 Tesla scans from 3 T to 4 T and 3 Tesla scans from 1.3 T to 2 T.

The new scanning parameters increase SAR limits for 1.5 Tesla scans from 0.5 W/kg to 2 W/kg and from 0.5 W/kg to 1.4 W/kg for 3 Tesla scans.

The new labeling reduces wait time from 60 to 5 minutes for maximum-duration scans (30 seconds).

In sacral neuromodulation, a small device delivers electrical impulses to the sacral nerves to improve bladder and bowel control, according to the release. This approach provides symptom relief through direct modulation of the nerve activity, compared with oral medications that target the muscular component of bladder control.

References:

• Medtronic. Medtronic receives FDA approval for expanded MRI labeling of InterStim SureScan MRI leads. Available at: https://news.medtronic.com/2021-02-18-Medtronic-Receives-FDA-Approval-for-Expanded-MRI-Labeling-of-InterStim-TM-SureScan-TM-MRI-Leads. Accessed Feb. 18, 2021.