StimGuard said it won another FDA Investigational Device Exemption to run a clinical trial of its percutaneously implantable device to treat urgency urinary incontinence as a result of refractory overactive bladder syndrome.
The StimGuard device utilizes a 1.3mm microchip neurostimulator designed to be implanted non-surgically with a needle. The stimulator communicates with a small external transmitter that can be worn discretely and requires no physical contact with the skin.
“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. Should the study results show effectiveness, StimGuard will have the ability to treat an underserved OAB patient population with a solution that is simple and not intimidating. We look forward to positive results from the study on the path to bring this technology to the urology market,” managing director Laura Tyler Perryman said in a press release.
The implanted device contains no batteries or upgrade components and is compatible with MRI scans, the Fort Lauderdale, Fla.-based company said. it is implanted in the tibial nerve to activate “afferent micturition”, or neural urinary, pathways.
“Physicians have been anticipating the evolution of tibial nerve stimulation with the potential to provide a minimally invasive, long-term implant neuromodulation treatment option for OAB,” Dr. David Staskin of Tufts University said in prepared remarks.
In May, the company won its 1st IDE clearance from the FDA to run a clinical trial of the device for patients suffering from overactive bladder syndrome, saying they expected the trial to begin earlier this year.
The same wireless technology used by StimGuard is already used by sister firm Stimwave Technologies to treat chronic back and leg pain. Last December Stimwave launched a clinical trialof its miniature, wireless neuromodulation anti-pain device for treating chronic, non-specific-origin lower back pain.
