StoryRegulatory
FDA approves InterStim Micro, a rechargeable sacral nerve stimulator, and InterStim SureScan MRI leads
MedtronicInterStim sacral neuromodulation (Micro / X)
Medtronic won FDA approval for InterStim Micro, a rechargeable implant for bladder and bowel control, together with new leads that allow full-body MRI scans. Medtronic said Micro is half the size of the only other rechargeable device on the market. Patients could now choose between a rechargeable and a recharge-free system.
- Treats overactive bladder, fecal incontinence and non-obstructive urinary retention.
- Battery rated for 15 years; recharges from empty to full in under an hour, weekly or monthly.
- SureScan leads allow 1.5 T and 3 T full-body MRI without impedance checks.
- Medtronic cited 25 years of sacral neuromodulation experience and five-year data.