The regulator’s consent is applicable for InterStim II and InterStim Micro sacral neuromodulation systems that use SureScan MRI leads
Medical technology company Medtronic has secured approval from the US Food and Drug Administration (FDA) for expanded MRI labeling of SureScan MRI leads.
The approval is applicable for InterStim II and InterStim Micro sacral neuromodulation (SNM) systems, which use SureScan MRI leads. SNM involves sending electrical impulses to the sacral nerves located in the lower back to improve bladder and bowel control, using a small device.
The updated MRI guidelines will also be applicable to existing and future implants of InterStim systems that use SureScan MRI leads.
Medtronic stated that the revised MRI labeling offers additional options to patients and physicians compared to the labeling of the other SNM system on the market.
The new SureScan MRI lead scanning parameters enhances B1+rms for 1.5 Tesla scans from 3.0 µT to 4.0 µT, and three Tesla scans from 1.3 µT to 2.0µT for MRI scanning facilities with B1+rms technology.
In addition, the new Medtronic scanning parameters enhances SAR limits for 1.5 Tesla scans from 0.5 W/kg to 2.0 W/kg and for three Tesla scans from 0.5 W/kg to 1.4 W/kg.
The new labeling also enables to reduce wait time from 60 minutes to five minutes for maximum duration scans (30 times).
Medtronic restorative therapies group’s pelvic health and gastric therapies president Brooke Story said: “Our updated InterStim SureScan MRI labeling 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.”
Earlier this month, Medtronic secured FDA approval for its DiamondTemp ablation (DTA) system for the treatment of atrial fibrillation.
The DiamondTem is designed for patients with recurrent, symptomatic paroxysmal atrial fibrillation (PAF) and who have been unresponsive to drug therapy.