The US Food and Drug Administration (FDA) has granted an investigational device exemption (IDE) approval to StimGuard to initiate a US clinical trial for a revolutionary wireless device to treat patients with overactive bladder syndrome (OAB).
StimGuard intends to use a passive microsize device, which can be implanted non-surgically through a needle, while a small external transmitter is easily and discreetly worn and attached to underwear, without coming in direct contact with the skin at anytime.
The technology does not feature internal batteries, which eliminates the requirement for extra surgeries to replace batteries or upgrade components, and is compatible with MRI scans.
In contrast, the legacy sacral nerve stimulation (SNS) therapy for OAB involves surgically implanting an electrode and a pulse generator with a non-rechargeable battery, requiring future surgical replacement.
Oakland University William Beaumont School of Medicine Urology professor Kenneth Peters said: "The majority of issues with the conventional SNS treatments have to do with the relatively large size of the devices and the need to replace the very expensive implantable pulse generators.
"StimGuard has the potential to eliminate those barriers through microtechnology."
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StimGuard co-founder Laura Tyler Perryman said: "With a product that eliminates the need for invasive and expensive surgery, we have the ability to access underserved OAB patients with a proven neurostimulation treatment."
Measuring 1.3mm in diameter, StimGuard’s electroceutical device is a tiny, injectable microchip that can deliver small pulses of energy to electrodes near surrounding nerves.
Wireless technology is already being used by Stimwave, another medical device company, to successfully provide relief for chronic back and leg pain in Europe and the US.
StimGuard is set to launch the clinical trial in mid-2015.
More than 33 million US citizens live with some level of OAB, and 200,000 of them are claimed to have received SNS treatment to alleviate severe symptoms.