Miniature wireless neurostimulation platform developer BlueWind Medical has secured approval from the US Food and Drug Administration (FDA) for study design for its RENOVA iStim system.
The approval will support the product’s marketing application in the US.
RENOVA iStim is a battery-less, leadless, miniature, implantable tibial nerve neuromodulation system, for the management of overactive bladder (OAB), including urinary urge incontinence.
The pivotal OverActive bladder StImulation System study (OASIS) is designed to evaluate the safety and effectiveness of the stimulation system to treat urinary urgency incontinence in patients who have failed or could not tolerate more conservative treatments.
The focus of the study will be on the proportion of responders to tibial therapy at six months post-implant based on a reduction in urinary urgency incontinence episodes from the baseline diary of the patient.
BlueWind will evaluate the safety and durability of the effect 12 months post-implantation. Patient enrollment is expected to start early next year.
The company aims to implant a total of 250 patients with RENOVA iStim at up to 25 medical centres, in several European countries, including the UK, Netherlands, Belgium and Germany.
In June 2016, RENOVA iStim system secured a CE Mark for the treatment of OAB.
In a pilot clinical study conducted in Europe, BlueWind demonstrated the safety and performance of the RENOVA iStim.
BlueWind was founded in 2010 by innovation and investment company Rainbow Medical, which is developing a platform technology of wireless neurostimulators that can be placed in minimally invasive procedures and treat multiple indications.
