FDA Green Light for StimGuard’s IDE Study into Implantable Overactive Bladder Device

Neurostimulator company, StimGuard has received U.S. FDA Investigational Device Exemption (IDE) approval to launch a clinical trial of the world’s first passive microsize implantable device for the treatment of Overactive Bladder Syndrome (OAB). The system utilizes wireless technology and is placed completely through a needle. The clinical trial will launch in summer 2015.

Background

More than 33 million Americans reportedly live with some level of OAB and treatments vary depending on the severity of the symptoms. Over 200,000 patients have received Sacral Nerve Stimulation (SNS) to alleviate severe symptoms, a procedure that involves surgically implanting an electrode and an implantable pulse generator, a relatively bulky device with a non-rechargeable battery requiring future surgical replacement.

In contrast, StimGuard has just one implanted component: a microsize neurostimulator that can be implanted non-surgically by using only a needle. A small external transmitter is easily and discreetly worn and attached to underwear and not directly in contact with the skin at anytime. With no internal batteries, StimGuard tells us its wireless technology eliminates the need for extra surgeries to replace batteries or upgrade components and is compatible with MRI scans, unlike the existing commercial options.

StimGuard utilizes Stimwave’s revolutionary electroceutical device – a tiny, injectable microchip that delivers small pulses of energy to electrodes near surrounding nerves.

Company comments

“StimGuard has the potential to revolutionize the treatment of OAB and dramatically improve the lives of millions of people,” said James McGivern, MBA, StimGuard’s Managing Director and a renowned medical device specialist with over 30 years experience in the industry. “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.”

“StimGuard introducing a completely percutaneous method for sacral stimulation is going to have a major impact on the field and open up many options for urologists,” said Laura Tyler Perryman, Managing Director and Co-Founder of the StimGuard device. “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. We look forward to positive results from the study and bringing forward this technology to the urology market.”

Investigator comments 

“We are thrilled about using this innovative technology to help patients manage the chronic and debilitating issue of overactive bladder,” said Kenneth Peters, MD, Professor and Chairman of Urology at Oakland University William Beaumont School of Medicine and a recognized authority on neuromodulation. “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.”

Source: Business Wire

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