Medical device firm StimGuard has obtained investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to carry out a clinical trial of the passive microsize implantable device for the treatment of overactive bladder syndrome (OAB).
The company plans to launch the US clinical trial in summer of this year.
The device will use wireless technology and it will have only one implanted component, a microsize neurostimulator that can be implanted non-surgically by using a needle.
StimGuard is said to use another medical device firm Stimwave’s electroceutical device, which is a tiny and injectable microchip that provides small pulses of energy to electrodes near surrounding nerves.
The device can be implanted in an outpatient procedure through a standard needle, as it is small in size with 1.3mm in diameter.
StimGuard managing director James McGivern said: "StimGuard has the potential to revolutionize the treatment of OAB and dramatically improve the lives of millions of people.
"We are excited to be at this stage of testing the efficacy of this next generation medical treatment for indications including urinary urge incontinence. We anticipate very promising outcomes."
Stimwave is currently using the StimGuard’s wireless technology to treat chronic back and leg pain in Europe and the US.