Avation Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its smart bladder control system, Vivally.
The non-invasive, bladder-control therapy device and mobile application is intended for the treatment of patients with urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome.
The Vivally system helps avoid surgery, drugs or needle electrodes. It is also claimed to be the only approved closed-loop and non-invasive neuromodulation system for bladder control in the US.
The closed-loop control uses the patient’s own physiologic response to objectively confirm activation of the tibial nerve. After activation, it also adjusts therapy parameters to ensure comfort and optimal therapeutic output.
Avation CEO Jill Schiaparelli said: “Millions of people suffer from urinary urgency and urge urinary incontinence who do not want invasive surgery or the unwanted side-effects of drugs.
“With 30-minute at-home therapy sessions as little as once per week, and a mobile application with an electronic bladder diary and progress tracking, Vivally provides an effective treatment option that patients can easily fit into their schedule.”
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The Vivally system enables the delivery of an electrical signal to the patient’s tibial nerve via an ankle-worn garment.
It is designed to provide personalised therapy for each patient for use at home.
To deliver therapy tailored to the needs of each patient, the Vivally Controller uses an advanced closed-loop control algorithm and electromyography.
The prospective and multi-centre FREEOAB study, which involved 96 patients with an overactive bladder, assessed the safety and effectiveness of the Vivally system.
Avation plans to make the system available in select geographies from the second quarter of this year.