StimGuard Receives CE Mark Approval for World’s First Battery-Free, Wireless Sacral Nerve Stimulator for Overactive Bladder

May 17, 2018

POMPANO BEACH, Fla.--(BUSINESS WIRE)--May 17, 2018--StimGuard LLC, a privately-held, pre-commercial medical device company headquartered in South Florida, today announced it received CE Mark approval for the world’s first wireless programmable neuromodulation device that can be introduced through a needle without surgery for treating chronic, intractable symptoms of overactive bladder. The device will be available in Europe beginning Summer 2018.

Representing a life-changing technological breakthrough for the more than 100 million people worldwide who have an overactive bladder, the StimGuard Sacral Nerve Stimulation (SNS) System is the most versatile system available in the industry. The CE Marked StimGuard SNS System can provide European patients with the same traditional SNS currently available, but the implant is 95 percent smaller than anything on the market. The StimGuard SNS System utilizes the Apple iPad as its programmer, allowing for advanced programming and widespread availability for all markets.

“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,” said Karl-Dietrich Sievert MD, PhD, professor and co-chairman of urology, University of Rocstock, Germany, and co-founder of StimGuard. “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 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, five percent 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. The StimGuard SNS System allows a European patient to experience the same stimulation parameters that have been clinically proven to relieve overactive bladder for over 15 years. 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.

“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,” said Kenneth M. Peters, M.D., a recognized leader in neuromodulation. “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.”

The CE Marked StimGuard SNS System is well positioned to revolutionize the urology industry in Europe. With the StimGuard SNS System, all programming is wireless, and, most importantly, upgradeable externally without any additional surgery.

Please visit stimguard.com for images and more information on the availability of the StimGuard SNS System in Europe.

About StimGuard

StimGuard is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective overactive bladder therapy solution that is easily incorporated into their daily lives. StimGuard’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of overactive bladder therapy. www.StimGuard.com

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SOURCE: StimGuard

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PUB: 05/17/2018 09:00 AM/DISC: 05/17/2018 09:00 AM


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