FDA grants 510(k) clearance to Vivally System for overactive bladder

The FDA has granted 510(k) clearance to the Vivally System, a wearable, non-invasive, bladder control therapy device and mobile application to treat patients with urinary urgency and urge urinary incontinence caused by overactive bladder syndrome.¹

The company intends for the Vivally System to be officially available in select areas of the United States by the middle of this year.

According to Avation Medical, Inc., the developer of the device, the Vivally System is a neuromodulation system, that uses a closed-loop control algorithm and electromyography to personalize treatment for each patient. The closed-loop control, “objectively confirms activation of the tibial nerve and continuously adjusts therapy parameters to ensure optimal output throughout the session,” according to the company.

The specific mechanism of the system involves an ankle-worn garment emitting an electrical signal to the patient’s tibial nerve. The patient’s physician calculates a therapy range personalized to a particular patient and then the system is prescribed for use in the patient’s home.

The safety and efficacy of Vivally were established in the FREEOAB study, a prospective multi-center clinical trial that included 96 patients with overactive bladder. Results of the study showed that with the Vivally System, 69% of patients were responders for urinary urgency at 6 months’ follow-up and 63% of patients were responders for urge incontinence at 6 months’ follow-up. The study defined a patient response as either showing a 50% or higher symptom improvement or a return to normal.

Study investigators surveyed patients on their experience with the Vivally System and 98% of patients responded that it was easy to use, according to Avation Medical.

Regarding safety, the investigators reported that there were no significant device-related adverse events that occurred during the study.

"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, stated in a press release. "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 company intends for the Vivally System to be officially available in select areas of the United States by the middle of this year.

Reference

1. Avation Medical Announces US FDA 510(k) Clearance for The Vivally® System, a wearable bladder control therapy and mobile app to treat patients with urinary urgency and urge urinary incontinence. Published online April 11, 2023. Accessed April 12, 2023. https://prn.to/3Uygoc7