Andrea Pezzella, MD, URPS, FACOG, discusses Neuspera's integrated sacral neuromodulation system

On June 18, 2025, the FDA granted clearance to Neuspera Medical’s integrated sacral neuromodulation (iSNM) system for the treatment of patients with urinary urge incontinence.¹ In this video, Andrea Pezzella, MD, URPS, FACOG, of Southern Urogynecology Wellness & Aesthetics in West Columbia, South Carolina, discusses the device, highlighting its significant advantages over traditional SNM systems. She said she believes Neuspera offers a "smart, integrated, sophisticated alternative" for treating overactive bladder symptoms. Pezzella considers it a "huge advancement in the next generation" of sacral neuromodulation.

A key benefit of Neuspera's system is its battery-free and daily external stimulation approach, which removes the burdens associated with implanted batteries and replacement surgeries. Pezzella initially thought battery replacement didn't significantly affect her practice, but she said she recently observed an "uptick" in battery replacements and revisions. This increase was due to factors such as conversions to MRI-compatible predicate devices requiring both battery and wire changes, and patients with rechargeable batteries struggling with charging due to movement or bulging, leading them to seek recharge-free options. These experiences have made the impact of battery-related issues more apparent in her practice.

Regarding efficacy, Pezzella notes that the SANS-UUI trial data show high response rates. She said she feels confident discussing its comparable effectiveness with patients against other predicate devices. She also mentions that practitioners often underestimate their infection rates and surgical complications like seromas and hematomas until they review their own data.

REFERENCE

1. Neuspera Medical receives FDA approval for first integrated sacral neuromodulation (iSNM) system for urinary urge incontinence. News release. Neuspera Medical. Published online and accessed June 18, 2025. https://www.prnewswire.com/news-releases/neuspera-medical-receives-fda-approval-for-first-integrated-sacral-neuromodulation-isnm-system-for-urinary-urge-incontinence-302484795.html