The updated MRI Guidelines facilitate an enhanced range of MRI scan parameters and reduced wait time between MRI scans
Medtronic has secured the US Food and Drug Administration (FDA) approval for expanded MRI labelling of its InterStim II and InterStim Micro sacral neuromodulation (SNM) systems using SureScan MRI leads.
The medical technology firm said that the updated MRI Guidelines facilitate an enhanced range of MRI scan parameters and reduced wait time between MRI scans.
The MRI label expansion applies to existing and future implants of InterStim systems that use SureScan MRI leads, and will improve patient access to MRI exams and offers flexibility for MRI providers.
Medtronic pelvic health and 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 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.”
The new SureScan MRI lead scanning parameters enhance MRI scanning facilities with B1+rms technology, the gold standard in MRI scanning technology, along with SAR limits.
Also, the new labelling reduces the wait time between MRI scans to five minutes for maximum duration scans from the previous 60 minutes.
Medtronic said that its SureScan MRI technology is already providing the benefit of eliminating impedance checks before an MRI scan and superior patient care.
The technology has been developed based on more than 19 years of full-body MRI research, 10 million simulated patient scans, and over 1.2 million unique scanning scenarios.
Sacral neuromodulation (SNM) uses a small device to send electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control.
SNM offers control of symptoms through direct modulation of the nerve activity and normalises the communication between the bladder and the brain.
Cleveland Clinic Glickman urological and kidney institute professor Howard Goldman said: “I’m pleased to see medical technology for SNM patients continue to improve. Optimal MRI labelling is an important enabler of greater access to therapy for patients and alleviates burdens on clinicians’ practices.”