Introduction: The BlueWind RENOVA iStim™ System is a novel miniature, leadless, battery-less, implantable tibial nerve stimulator, which provides a minimally invasive therapy focusing on a patient-centric home treatment. The pulse generator implant is wirelessly powered by a wearable unit that controls the therapeutic parameters and is worn by the patient during home treatment.
A pivotal trial is being conducted to evaluate the safety and efficacy of the RENOVA iStim System for treating refractory OAB patients.
Methods: women with urgency incontinence will be enrolled in this prospective, single arm, open-label study. Inclusion criteria required at least 1 urinary urgency incontinent (UUI) episode/day for 5 days. The device is implanted in the lower leg during a minimally invasive procedure in which it is secured superficial to the tibial neurovascular bundle, just below the fascia. The implant is activated ~4 weeks after implantation. The patient is instructed to apply the wearable unit (figure 1) and perform daily stimulation treatments at home for 30-120 minutes per day. Voiding diary data, quality of life questionnaires and patient satisfaction questionnaires are collected at 6, 12, 24 and 36 months after device activation and are compared to baseline.
Results: 151 subjects, mean age 58.9 (SD: 12.3), have been implanted in 9 centers in Europe and 14 centers in the US. The subjects demonstrated mean baseline of 4.72 UUI/day and 10 voids/day.
Out of the 151 subjects, 53 have 6 months follow-up and 17 have been followed for 12 months. To date, no device or procedure related Serious Adverse Events occurred. Out of 144 implanted patients whose adverse events (AEs) were adjudicated by an independent Clinical Events Committee, 7 had (4.8%) mild and 4 had (2.8%) moderate device or procedure AEs.
Conclusions: The aim of the BlueWind RENOVA iStim System is to refine the currently available therapies for refractory OAB patients, by providing a patient centric treatment that is less invasive and provides a durable response. Thus far, the implantation procedure and therapy yield a favorable safety profile and early results appear to be promising. This implantable tibial nerve technology with wireless energy potentially offers a long-term treatment option for this chronic medical condition, without the need for battery changes in the implantable component. Patient-controlled home stimulation may allow stimulation sessions, customizable to a patient's needs, and perhaps eliciting more rapid clinical improvement.
Source of Funding: BlueWind Medical is the sponsor of the OASIS trial
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