Avation Medical: Vivally Bladder Control Device

2023: The Device Enters the Market

On April 14, 2023, it was reported that the company, Avation Medical a developer of neuromodulation devices for the therapy of quality-of-life changing diseases, received permission FDA (from the Food and Drug Administration) through procedure 510 (k) for its development called Vivally. Thanks to the permission received, Avation Medical expects to launch sales of such devices in some regions in the second quarter of 2023. USA^[1]

The bladder control device from Avation Medical will soon be on sale
Ha photo: Vivally system
Photo: avation.com

Vivally's system includes a non-invasive bladder control device and a mobile app. The development is designed to help patients with urgent conditions and urinary incontinence caused by overactive bladder syndrome. The procedure for using the device does not involve surgery, the use of drugs or needle electrodes.

As noted, the occurrence of sudden, strong and intractable urge to urinate and incontinence is a very common and debilitating chronic disease estimated to affect millions of women and men worldwide. Despite the presence of several effective treatments, very low levels of patient acceptance and poor adherence to therapy remain.

Many patients do not want to resort to invasive surgery or are afraid of unwanted side effects from drugs. Vivally's neuromodulation system offers an alternative treatment option that involves conducting 30-minute therapy sessions at home just once a week. Patients can easily fit such procedures into their daily routine. At the same time, a mobile application with an electronic diary allows them to independently track progress.

The Vivally system is worn on the ankle and works by applying an electrical signal to the patient's tibial nerve. The doctor creates an individual therapy complex for each patient and prescribes a Vivally system for use at home. The Vivally controller uses a patented closed-loop control algorithm and electromyography technology, which allows continuous adjustment of therapy parameters to ensure an optimal result throughout the session.

The safety and efficacy of Vivally was evaluated in a multicenter clinical trial involving 96 patients with overactive bladder. After six months, 69% of subjects responded to the treatment of urinary urination and 63% to urinary incontinence. At the same time, a person whose symptoms improved by at least 50% or returned to normal is considered to have "reacted." 98% of subjects noted the ease of use of the Vivally system. No significant adverse events related to the device were noted during the study.

As of the date of receipt of the FDA opinion, Vivally was the only closed non-invasive neuromodulation system for bladder control authorized for sale in the United States.^[2]

Notes