Home » StimGuard Receives FDA IDE Designation for Microsize Bladder Device
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
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