StimGuard said yesterday that preliminary patient outcomes from a long-term trial of its over-active bladder stimulation device showed positive results.
Patient outcomes from the ongoing trial show reductions in voiding episodes and 80% relief from symptoms in patients who were implanted with the device last year, the Miami-based company said.
“I am pleased to report that our 2 patients who presented with OAB and a variety of other medical complications had long-term positive outcomes and a reduction in incontinence episodes of greater than 80% on average, positively affecting their quality of life. The procedure was simple to perform, and I look forward to treating many patients with this novel therapy, which can be administered in a less costly way than other neuromodulation options,” Dr. Karl-Dietrich Sievert, of Zurich’s University of Salzburg, said in a press release.
The Stimguard system is designed to use an injectable microchip device, implanted along the tibial nerve, to deliver small pulses of energy to electrodes, the company said. This triggers a reaction that enables the brain to remap specific urge signals. Neuromodulation has been approved to treat OAB since 1997, the company added, though most procedures require numerous implants and clinic visits.
“The therapy is utilized for just 8 hours a day, so it can be conveniently administered using only a sock worn during the evening or overnight. Chronic tibial stimulation affects multiple afferent paths to the micturition centers, possibly better serving patients than classic sacral neurostimulation over the long term,” StimGuard director James McGivern said in prepared remarks.
StimGuard won FDA approval for IDE testing of the device earlier this month, and said it will seek FDA approval in 2016. The company plans to complete regulatory studies for CE Mark approval in the European Union in 2015.