FDA Green Lights Trial of RENOVA iStim Tibial Nerve Neuromodulation System for OAB

The US Food and Drug Administration (FDA) has approved the proposed study design for BlueWind Medical’s RENOVA iStim system, a battery-less, miniature, implantable tibial nerve neuromodulation system intended for the management of overactive bladder (OAB).

The system includes technology to manage the adverse effects of urinary urge incontinence as well as symptoms of urgency-frequency, which impact a large group of the 109 million patients with OAB in the United States and European Union.

Dubbed the Overactive Bladder Stimulation System study—or OASIS—the trial will seek to enroll 250 patients at up to 25 medical centers located in the UK, the Netherlands, Belguim, and Germany. It will begin enrollment in early 2019 and will evaluate the safety and efficacy of the tibial nerve neuromodulation system in patients who have failed or were intolerant to a more conservative treatment option.

The analysis in the study will focus, “among other things,” BlueWind Medical noted, on the proportion of those who respond to tibial therapy at the 6-month mark, post-implantation. This will be measured based on the reduction in urinary urgency incontinence episodes from baseline measurements. The safety and durability of that potential effect will be assessed 12 months post-implantation.

The RENOVA iStim system was granted a CE Mark of approval for the treatment of OAB on June 15, 2016. In the trial data assessed to gain that authorization of use, it was shown that 70.6% of the patients in the overall cohort experienced at least a ≥50% reduction in symptoms or a return to normal rates of bowel voidance at the 6-month mark.

Additionally, at the 1-month mark post-activation, upward of 50% of patients reported a 50% or greater relief of symptoms. According to BlueWind, “this high rate of responders coincides with a significant improvement in all aspects of OAB health-related quality of life.”

The device itself is quite small, 0.3 cc in volume and 3.4 mm in diameter, with the device wearable on the ankle. The simulator part of the device is implanted in the patient via a small incision and then fixated with a suture—a process that can be completed in roughly 30 minutes with local anesthesia. BlueWind noted that “there is no need to expose the target nerve, as the device is placed in the vicinity of the neurovascular bundle.