Avation Medical, a developer of closed-loop neuromodulation options to treat life-altering medical conditions, has received US Food and Drug Administration (FDA) 510(k) clearance for its Vivally System.
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Stamp of FDA approval
Vivally is a non-invasive, bladder control therapy device and mobile application to treat patients with the conditions of urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (OAB) syndrome, without the need for surgery, drugs, or needle-electrodes.
The Vivally System is the only closed-loop, non-invasive neuromodulation system for bladder control cleared for sale in the United States. Closed-loop control objectively confirms activation of the tibial nerve and continuously adjusts therapy parameters to ensure optimal output throughout the session.
Jill Schiaparelli, Avation CEO, 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.”
Urinary urgency and UUI are the primary symptoms of OAB, a highly prevalent and debilitating chronic condition that is estimated to impact more than 42 million women and men in the United States. Despite the availability of several effective treatments, very low rates of patient adoption and poor therapy compliance persist.
The Vivally System works by providing an electrical signal to the patient’s tibial nerve through an ankle-worn garment. A clinician creates a personalised therapy range for each patient and prescribes the Vivally System for use in the home. The Vivally Controller uses a proprietary closed-loop control algorithm and electromyography (EMG) to offer personalised therapy for each patient.
Vivally’s safety and effectiveness were evaluated in a prospective, multi-centre clinical study of 96 subjects with overactive bladder (the FREEOAB Study). At six months, 69% of subjects were responders for urinary urgency and 63% for urge incontinence, where a responder is a subject showing at least 50% symptom improvement or a return to normal. 98% of subjects found the Vivally System easy to use. There were no significant device-related adverse events during the study.
The Vivally System will be available in select geographies beginning in Q2 2023.
