Sam Brusco, Associate Editor04.12.23
Avation Medical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Vivally system, a non-invasive, bladder control therapy device and mobile application to treat urinary urgency and urge urinary incontinence (UUI) caused by overactive bladder (AOB) syndrome.
Vivally doesn’t need surgery, drugs, or needle-electrodes. It is a closed-loop, non-invasive neuromodulation system that confirms activation of the tibial nerve and continuously adjusts therapy parameters for optimal output throughout the session.
"Millions of people suffer from urinary urgency and urge urinary incontinence who do not want invasive surgery or the unwanted side-effects of drugs," Jill Schiaparelli, Avation CEO told the press. "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."
The system provides an electrical signal to the tibial nerve via an ankle-worn garment. A clinician creates a personalized therapy range and prescribes Vivally’s use in the home. The device’s proprietary, closed-loop algorithm and electromyography (EMG) provides the personalized therapy.
A 96-subject study of patients with OAB showed 69% of subjects were responders for urinary urgency and 63% for urge incontinence— 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.
Avation intends to release the system in select geographies beginning Q2 2023.
Vivally doesn’t need surgery, drugs, or needle-electrodes. It is a closed-loop, non-invasive neuromodulation system that confirms activation of the tibial nerve and continuously adjusts therapy parameters for optimal output throughout the session.
"Millions of people suffer from urinary urgency and urge urinary incontinence who do not want invasive surgery or the unwanted side-effects of drugs," Jill Schiaparelli, Avation CEO told the press. "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."
The system provides an electrical signal to the tibial nerve via an ankle-worn garment. A clinician creates a personalized therapy range and prescribes Vivally’s use in the home. The device’s proprietary, closed-loop algorithm and electromyography (EMG) provides the personalized therapy.
A 96-subject study of patients with OAB showed 69% of subjects were responders for urinary urgency and 63% for urge incontinence— 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.
Avation intends to release the system in select geographies beginning Q2 2023.