February 2026 issue, BioElectRx Business Report
February 28, 2026 | Competition in the market for tibial nerve stimulation systems to treat overactive bladder continues to intensify in the months following Boston Scientific’s, announcement to acquire Valencia Technologies [BBR Jan26 p6]. Earlier this month, Medtronic, which already competes with Boston Scientific in the implanted sacral nerve stimulation market, published positive results for its Altaviva TNS system in The Journal of Urology. Data from the TITAN 2 pivotal clinical trial demonstrates that the Altaviva device delivers significant and sustained symptoms at 12 months, while maintaining a favorable safety profile. The TITAN 2 pivotal study imposed the strictest requirements for prior drug failure and drug discontinuation among implantable tibial neuromodulation clinical trials and included patients with various BMI and comorbidities.
All primary and secondary endpoints in this study were met, with sustained improvement through 12 months. Approximately 20% of patients had no UUI episodes at all at 12 months. Also, 80% of patients reported their condition improved according to the Patient Global Impression of Improvement. At 12 months, 61% of study participants maintained at least 50% reduction in daily UUI episodes.
“The TITAN 2 12-month data show that the Altaviva implantable tibial neuromodulation device can provide meaningful, durable symptom improvement for patients with urge urinary incontinence who have not responded to traditional therapies,” said Keith Xavier of Urology Partners in North Texas. “Notably, these outcomes were achieved without the use of concurrent medications, and almost 30% of the study participants had tried previous advanced OAB options, highlighting the potential for sustained symptom relief among the real-world patient population.”
Meanwhile, another vendor of implantable TNS systems, BlueWind Medical, developer of the Revi system, announced that three-year results from its pivotal OASIS study were presented by CMO Roger Dmochowski at the SUFU 2026 winter meeting. The data confirm Revi’s sustained efficacy, excellent safety, and exceptional patient satisfaction, reinforcing its position as the most clinically validated iTNM therapy for UUI currently available. The OASIS study is a prospective, multicenter, single-arm, open-label clinical study involving 151 adult women with UUI. The trial evaluated the efficacy and safety of Revi in treating UUI symptoms in patients with OAB.
Key findings from the three-year data include exceptional patient satisfaction: 95% reported therapeutic satisfaction at 36 months; durable long-term benefit: therapeutic effectiveness maintained from 6 to 36 months; and high responder rate: 79% of participants were therapy responders. Also, nocturia episodes decreased from 1.3 to 0.9 per day and significant and sustained decreases were observed in both UUI episodes and large urgency-related leaks through 36 months.No device- or procedure-related serious adverse events were reported through 36 months.
“With the most comprehensive and longest-term data in implantable tibial neuromodulation, BlueWind has set a new benchmark for durable, patient-centered therapy for UUI,” said Dmochowski. “Revi delivers consistent, long-lasting outcomes, proving that effective, minimally invasive treatment can be both simple and transformative. These results reinforce Revi’s position as the gold standard for clinical evidence, patient satisfaction, and sustained quality-of-life improvement in urgency urinary incontinence.”
Implanted near the ankle in a single outpatient procedure under local anesthesia, Revi delivers targeted stimulation to the posterior tibial nerve via a lightweight, external wearable. Patients activate therapy once daily at home, without the need for internal batteries or leads, avoiding complications such as lead fracture, migration, or battery depletion.
