StimGuard Receives FDA IDE Designation for Microsize Bladder Device
StimGuard’s wireless microsize Overactive Bladder Syndrome implantable device, capable of being placed completely through a needle, has won an Investigational Device Exemption from the FDA, the devicemaker announced Monday.
Unlike traditional OAB treatment, which requires a large implantable pulse generator, the device does not require a surgical incision. Rather, the product uses the Stimwave electroceutical microchip to administer small energy pulses to electrodes near surrounding nerves.
The device’s treatment therapy, Sacral Nerve Stimulation, has been FDA-approved for severe OAB since 1997.
A clinical trial is scheduled for this summer. More than 33 million people are afflicted with OAB in the U.S. — Jason Scott