Pompano Beach, Fla.-based StimGuard is already running a pivotal study of its technology, a miniature implantable device designed to treat urinary incontinence resulting from refractory overactive bladder syndrome. The device is implanted at the tibial nerve through a needle-sized introducer and uses wireless technology to stimulate the nerve.
The new study is designed to compare that treatment with InterStim sacral nerve stimulation therapy, which involves the surgical implantation of lead at the sacral nerve and a battery unit (StimGuard’s device uses an external transmitter).
StimGuard said it plans to commercialize the technology if the study proves successful.
“An electrode implanted at the tibial nerve in an office setting, with the potential to provide the same outcomes as sacral neuromodulation, will be a game-changing option for urgency urinary incontinence associated with OAB,” StimGuard consultant Dr. Kenneth Peters, of Oakland University’s William Beaumont School of Medicine, said in prepared remarks. “StimGuard’s innovative technology has the potential to provide similar outcomes as sacral nerve stimulation in an office based procedure, which could drastically reduce the cost of care while allowing more patients to be treated, improving accessibility to a non-drug treatment option for many patients with OAB.”
Last July Medtronic touted 5-year results from the InSite study of InterStim.