StimGuard has secured CE Mark approval for what is claimed to be world’s first battery-free, wireless sacral nerve stimulator for overactive bladder.
The StimGuard Sacral Nerve Stimulation (SNS) system can be introduced through a needle without surgery. It will be available across Europe, starting this summer.
The device is expected to be life-changing technological breakthrough for more than 100 million people worldwide with overactive bladder.
The CE Marked StimGuard SNS System can provide European patients with the same traditional SNS currently available, but the implant is 95% smaller than the products available in the market today.
One major advantage of the StimGuard SNS system is that it eliminates the need for an implanted battery source, called an IPG which is needed by the other SNS devices in the market.
The device has electrode contacts and embedded chip being placed within the body through a needed mated with a wire receiver, enabling a lower cost option. The system allows a patient to experience the same stimulation parameters that have been clinically proven to relieve overactive bladder for over 15 years.
In other systems, patient will undergo an invasive surgery to have a battery pack surgically implanted under his or her skin. The battery pack will have to be replaced every three to five years, but with StimGuard SNS System, this procedure is eliminated.
University of Rocstock co-chairman and urology professor and StimGuard co-founder Karl-Dietrich Sievert said: “A wireless system that enables urologists to inject such a clinically proven therapy represents a shift in the field where there has only been one option for over 15 years.
“The ability of the CE Marked StimGuard SNS System to offer the same level of stimulation at the micro-wireless level will give patients an alternative to a bulky battery or excessive invasive surgeries, but still provide the same control.”
As perStimGuard, the CE Marked SNS System is positioned to revolutionize urology industry in Europe. In the system, all the programming is wireless and most importantly, it is externally upgradeable without any additional surgery.
Recognized leader in neuromodulation Kenneth M. Peters said: “Prior to the StimGuard system, we would need to make a large incision to implant a battery-powered generator, and complications, such as pain at the generator site, infection, erosion and reoperation, were common.
“The battery typically lasted four to five years and replacement resulted in additional surgery and substantial cost to the healthcare system. Finally, this technology is an option for patients that makes sacral neuromodulation a minimally-invasive procedure.”