StimGuard Wins FDA Approval to Conduct Trial of OAB Device
StimGuard has received FDA approval to conduct a clinical trial of a percutaneously implantable device for treating urgency urinary incontinence caused by overactive bladder syndrome.
Utilizing wireless technology, the device is placed through a needle at the tibial nerve to activate the neural urinary pathways.
The will launch this winter and evaluate the effectiveness of delivering pulsed electrical energy to surrounding tibial nerves that prompt the sacral nerves to regulate the bladder.
“If successfully trialed, the StimGuard technology would allow neuromodulation to be offered to patients in an office setting, which has never been the case before for a permanent, long-term treatment of urinary urge incontinence associated with OAB,” says Laura, Perryman, managing director and cofounder of the Fort Lauderdale, Fla., firm. — Michael Cipriano