Vivally System for overactive bladder granted MedTech Breakthrough Award

The 2023 MedTech Breakthrough Award for Healthcare Wearables Innovation has been granted 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

"As the first FDA cleared closed-loop, non-invasive neuromodulation system to treat incontinence and urinary urge, we are honored to receive the Healthcare Wearables Innovation Award from MedTech Breakthrough," said Jill Schiaparelli, CEO of Avation.

The MedTech Breakthrough Award program acknowledges excellence in digital health and medical technology across the areas of products, services, and companies.

Vivally System is a neuromodulation system that uses a closed-loop control algorithm and electromyography to personalize treatment for each patient, according to Avation Medical, Inc., the developer of the device. 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.²

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.

In April 2023, 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.²

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.

"As the first FDA cleared closed-loop, non-invasive neuromodulation system to treat incontinence and urinary urge, we are honored to receive the Healthcare Wearables Innovation Award from MedTech Breakthrough," Jill Schiaparelli, CEO of Avation, stated in a press release.² "We listened carefully to patients and designed Vivally as a wearable neuromodulation therapy that does not require surgery or an implant and can be used in the home for 30 minutes as little as once per week. We also paired it with a mobile application to provide each patient with a full system of therapy and support."

Reference

1. Avation Medical's Bladder Control Therapy Receives Award for Most Innovative Wearable. Published online May 8, 2023. https://prn.to/3pitv5F

2. 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