StimGuard, a medical device manufacturer and independent research institute headquartered in Miami Beach, Florida, announced positive results for long-term patients using the world’s first wireless micro-technology injectable tibial stimulator for the relief of overactive bladder (OAB).
The device was placed last year in Zurich, Switzerland by leading urology pioneer Karl-Dietrich Sievert, M.D., chairman of Urology at the University of Salzburg. Patient outcomes show ongoing reduction of voiding episodes and more than 80 percent relief with a therapy that is administered only at night.
These preliminary results represent a life-changing technological breakthrough for the more than 200 million people worldwide that are afflicted with incontinence.
To date, patients have had to make office visits routinely or undergo a surgery in the OR to utilize neuromodulation for relief of their OAB symptoms. The StimGuard technology, developed by scientists and engineers led by co-inventor and StimGuard Chairman Laura Tyler Perryman, uses a tiny injectable microchip device placed through a small needle that delivers small pulses of energy to electrodes near surrounding nerves, triggering a reaction that enables the brain to remap specific urge signals.
"The therapy is utilized for just eight hours a day, so it can be conveniently administered using only a sock worn during the evening or overnight," said industry veteran and StimGuard Director James McGivern.
Dr. Sievert conducted the procedures live at the 2014 Swiss Continence Foundation Conference in Zurich last August. "I am pleased to report that our two patients who presented with OAB and a variety of other medical complications had long term positive outcomes and a reduction in incontinence episodes of greater than 80 percent on average, positively affecting their quality of life," said Sievert.
While neuromodulation has been used for the treatment of OAB since 1997 with expensive systems and numerous large implanted parts and batteries, StimGuard’s novel tibial placement procedure requires just one implanted component: a microsize neurostimulator that can be implanted non-surgically by using only a needle and without the need for imaging equipment.
This treatment offers a minimally-invasive, outpatient office procedure resulting in a lower cost option for the industry and a patient option that is widely accepted since it is similar to acupuncture, but permanent.
StimGuard conducted short-term pilot studies in 2013 with encouraging results for the chronic tibial neurostimulation concept. The company plans to complete regulatory studies for CE Mark in 2015 and to seek FDA approval in 2016.