Neuspera Medical’s Integrated Sacral Neuromodulation System Secures the US FDA Approval for Urinary Urge Incontinence
Shots:
- The US FDA has approved integrated sacral neuromodulation (iSNM) system to treat urinary urge incontinence (UUI)
- iSNM device was evaluated in a P-II trial in 128 pts, which showed 84.2% pts achieved ≥50% reduction in urgent leaks, with 84% & 42% responders experiencing >75% & 100% reduction, respectively in UUI symptoms at 6mos.; 3.5x improvement in QoL was also observed
- iSNM device consist of a smart, miniaturized neurostimulator which is implanted near the sacral nerve & an external disc worn on the lower back for ~2hrs daily to activate therapy, allowing neuromodulation therapy delivery while eliminating battery-related complications
Ref: Prnewswire | Image: Neuspera Medical| Press Release
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