Medtronic (NYSE:MDT) announced today that it received FDA approval for expanded MRI labeling of its InterStim SNM systems.
Fridley, Minn.-based Medtronic’s InterStim II and InterStim Micro sacral neuromodulation (SNM) systems that use SureScan MRI leads were approved under updated MRI guidelines allowing for a wider range of MRI scan parameters and shorter wait times between scans, according to a news release.
Medtronic’s InterStim SNM systems use a small device to send electrical impulses to sacral nerves in the lower back in an effort to improve bladder and bowel control.
With application to existing and future implants of InterStim systems that use SureScan MRI leads, the expanded labeling is designed to improve patient access to MRI exams and add flexibility for MRI providers, Medtronic said.
The guideline updates are in addition to what is already provided by SureScan MRI technology. They provide new scanning parameters and decrease the wait time from 60 minutes to five minutes for maximum duration scans (30 minutes).
“Our updated InterStim SureScan MRI labeling means the best choice in SNM therapy keeps getting better,” Medtronic president of pelvic health & gastric therapies Brooke Story said in the release. “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.”
