Bioness Initiates Pilot Study of StimRouter Device

Bioness has begun a Canadian pilot study of its StimRouter Nueromodulation System for overactive bladder, following receipt of FDA 510(k) clearance in February. The device already has been successfully implanted in four patients, the Valencia, Calif, company announced.

StimRouter — a minimally invasive neuromodulation medical device comprised of an implanted lead, external pulse transmitter and conductive electrode — has been indicated by the FDA to treat chronic, intractable pain originating from the peripheral nerve. It is being examined as an alternative treatment for overactive bladder, the devicemaker said.

During the six-month clinical trial, patients will undergo tibial nerve stimulation via the StimRouter implantable lead and external pulse transmitter. Patients will then manage their own treatment at home with periodic in-clinic outcome visits, the StimRouter having the ability to track patient usage and compliance.

The device has the potential to be expanded for further indications, with the pilot study being the first of several investigations toward this end, Bioness president Todd Cushman said Friday.

An estimated 33 million Americans suffer from overactive bladder, the FDA said in a January news release. — Jason Scott