The BlueWind Medical system (figure 1) is a novel miniature, leadless, battery-less, sub-facially implantable tibial neuromodulation system (iTNM).  The implant is wirelessly powered and modulated by an external wearable unit. A Clinician Programmer tablet is used to individually tailor stimulation parameters (i.e., frequency, pulse width, polarity and amplitude). 
As a patient-centric modality, bespoke optimization of treatment potentially improves patient compliance and patient satisfaction which is key to the treatment outcomes.
This pivotal trial was conducted to evaluate the safety and efficacy of the BlueWind Medical Device for treating Urge Urinary Incontinence (UUI) in women.

Women were enrolled in this prospective, single arm, open-label study. Inclusion criteria required at least 9 UUI episodes per 7-day diary.  The study was conducted at 23 centers in the United States and Europe. The device is implanted in the lower leg under local anesthetic in a minimally invasive procedure designed to secure the device adjacent to the tibial neurovascular bundle. Suturing the device to the fascia mitigated risk of migration and permitted patients to be mobile after surgery.  The implant is activated at ~4 weeks after implantation. The patients were instructed to use the wearable device and perform treatments daily for 30-120 minutes stimulation sessions at home. 
Stimulation programs were individualized according to a predefined algorithm for non-responders or partial responders . Multiple treatment programs were set when needed to allow patients to switch between programs at home.
Efficacy endpoints were UUI episodes at 6 and 12 months compared to baseline.  Safety endpoint was incidence of adverse events at 12 months post implantation.

No implantation or device related Serious Adverse Events(SAE’s) were recorded during the study. There were no unanticipated adverse device effects. Of the 151 subjects implanted with the device, only 6 patients (4.0%) experienced device related adverse events.   Device related AEs were pain with stimulation/implant, and either resolved spontaneously or were treated with reprogramming, or with antibiotic treatment (although no indication or confirmation of infection existed).
There were 10 surgical wound related adverse events, all of which were either mild or moderate in nature. Other surgical procedure related AEs (n=6, 4.0%) were also classified as either mild or moderate and included numbness after surgery, swollen foot, allergic reaction, skin rash, cellulitis, pain. Intent To Treat:78.4% of subjects had a greater than 50% reduction in UUI episodes.  Sixty seven percent of the patients who completed 12 month follow up achieved ≥ 75% reduction in UUI episodes.  Fifty percent reported complete resolution of incontinence and were “dry” at 12 months (defined as 3 consecutive diary days without leaks). 
The patient centric approach allowed patients not only to control the intensity of their stimulation but also to perform treatment at their convenience which was reflected by the high compliance rate (91.6%) and patient satisfaction (95%).

The BlueWind Medical Device has demonstrated a favorable safety profile with no device or procedure related SAEs and a low rate of AE’s
Efficacy achieved during the study was durable with a growing proportion of responders throughout the 12 months follow-up period (figure 2).  
The ability to adjust stimulation parameters as well as the duration of stimulation, without the concern of battery depletion, permits individual tailoring of the treatment per patient’s sensation and response, increasing response to therapy and satisfaction.

The BlueWind iTNM system is a single step (i.e. no trialing) minimally invasive and safe procedure with high and sustained efficacy over 12-months.  The system allows patients to control when and where treatment is delivered and to tailor therapy parameters and intervals to their specific symptom complex.

Continence 7S1 (2023) 100937
DOI: 10.1016/j.cont.2023.100937