CE mark for overactive bladder neuromodulation device


StimGuard has received a CE mark for a wireless neuromodulation device to treat chronic symptoms of overactive bladder.

“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,” Karl-Dietrich Sievert, professor and co-chairman of urology, University of Rocstock, Germany, and co-founder of StimGuard, said in a release. “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.”

The company said the major advantage of the StimGuard SNS system is the elimination of the implanted battery source (a pacemaker-like device), called an IPG, required by the other SNS device on the market. With the StimGuard technology, only a small device, 5% of the size of the other option, with electrode contacts and an embedded chip is placed within the body through a needle mated with a wire receiver, enabling a potentially lower-cost option. With other systems, the patient undergoes an invasive surgery to have a battery pack surgically implanted under their skin. The battery pack would have to be replaced every three to five years, which is eliminated with the StimGuard SNS System.


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