StimGuard said today it won CE Mark approval in the European Union for its sacral nerve stimulator designed to treat intractable symptoms of overactive bladder, with plans to launch the device in the EU this summer.
The Pompany Beach, Fla.-based company touted that the StimGuard SNS system can be implanted through a needle without a surgery, as the device is 95% smaller than other similar sacral nerve stimulation devices on the market. The system uses an Apple iPad as a programming console, the company added.
“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 co-founder Dr. Karl-Dietrich Sievert said in a prepared statement.
The recently cleared StimGuard SNS system removes the necessity for an implanted battery source, and is upgradeable externally without the need for future surgeries, the company 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,” Dr. Kenneth Peters said in a press release.