StimGuard secures CE-Mark for wireless nerve stimulator

21 May 2018 (Last Updated May 21st, 2018 11:32)

US-based medical device firm StimGuard has secured the European CE-Mark for its battery-free, wireless neuromodulation device designed to stimulate the sacral nerve to address overactive bladder.

US-based medical device firm StimGuard has secured the European CE-Mark for its battery-free, wireless neuromodulation device designed to stimulate the sacral nerve to address overactive bladder.

The programmable StimGuard Sacral Nerve Stimulation (SNS) System can be implanted using a needle, eliminating the need for surgery, to treat chronic, intractable symptoms of the condition.

According to StimGuard, the new system is 95% smaller than other similar implants in the market but can offer same standard stimulation of the nerve. The device leverages Apple iPad as its programmer.

Existing SNS devices come with a battery source, which has to be implanted under patients’ skin through an invasive surgery and requires replacement every three to five years.

“The programmable StimGuard Sacral Nerve Stimulation (SNS) System can be implanted using a needle, eliminating the need for surgery, to treat chronic, intractable symptoms of the condition.”

In the StimGuard system, this battery pack has been replaced with electrode contacts and an embedded chip that can be upgraded externally without additional surgery.

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.”

StimGuard develops, manufactures and commercialises wirelessly powered, injectable microtechnology neurostimulators to deliver safe, minimally invasive and cost-effective solutions for overactive bladder.

The company aims to advance its neuromodulation platform, boost accessibility and at the same time minimise the economic impact of therapy for the condition.