It’s only a couple of weeks since StimGuard LLC, told us it had gained the FDA’s nod for it to commence an IDE study that would presage market approval. Now the company is pouring some more fuel on its own fire by pointing us at positive results for long-term patient use of its wireless micro-technology injectable tibial stimulator for the relief of overactive bladder (OAB).
Neuromodulation has been used for the treatment of OAB since 1997 with expensive systems and numerous large implanted parts and batteries. At the present time, patients have had to make office visits routinely or undergo a surgery in the OR to utilize neuromodulation for relief of their OAB symptoms.
In contrast, the StimGuard system, 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 novel tibial placement procedure requires just one component, 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 and a patient option that is widely accepted since it is similar to acupuncture, but permanent.
The newly touted clinical findings relate to two implantations which took place last year in Zurich, Switzerland by leading urology pioneer Karl-Dietrich Sievert, M.D., chairman of Urology at the University of Salzburg. Albeit only two patients, outcomes show ongoing reduction of voiding episodes and more than 80 percent relief with a therapy that is administered only at night.
These preliminary signs could be the precursor of life-changing treatment for the more than 200 million people worldwide that are afflicted with incontinence. The company plans to complete regulatory studies for CE Mark in 2015 and to seek FDA approval in 2016.
“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. “Chronic tibial stimulation affects multiple afferent paths to the micturition centers, possibly better serving patients than classic sacral neurostimulation over the long term.”
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. “The procedure was simple to perform, and I look forward to treating many patients with this novel therapy, which can be administered in a less costly way than other neuromodulation options.”
“I am extremely excited about this new technology developed by StimGuard. Now people with overactive bladder will have additional options, including the ability to receive a permanent implant with a far less invasive and complicated surgery in an office setting,” said Chris Winters, M.D., chairman of the Department of Urology, Louisiana State University. “The StimGuard Tibial System is well positioned to revolutionize the urology industry with an interventional method that most urologists will be able to easily integrate into their practices.”
Source: Business Wire