StimGuard said it won an investigational device exemption from the FDA for a clinical trial of its micro-size implantable device to treat overactive bladder syndrome. StimGuard said its system uses a small injectable microchip and an external transmitter and requires no invasive surgery to implant. The trial is slated to begin in summer 2015.
"Introducing a completely percutaneous method for sacral stimulation is going to have a major impact on the field and open up many options for urologists. With a product that eliminates the need for invasive and expensive surgery, we have the ability to access underserved OAB patients with a proven neurostimulation treatment. We look forward to positive results from the study and bringing forward this technology to the urology market," co-founder an managing director Laura Tyler Perryman said in prepared remarks.
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. The implanted device contains no batteries or upgrade components and is compatible with MRI scans.
“StimGuard has the potential to revolutionize the treatment of OAB and dramatically improve the lives of millions of people. We are excited to be at this stage of testing the efficacy of this next generation medical treatment for indications including urinary urge incontinence. We anticipate very promising outcomes,” managing director James McGivern said in a press release.
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 trial of its miniature, wireless neuromodulation anti-pain device for treating chronic, non-specific-origin lower back pain.