Avation’s Vivally® System dramatically changes treatment of urinary incontinence and urgency caused by overactive bladder, eliminating the need for surgery, drugs, and needles, allowing clinicians to treat more patients
Columbus, OH (Feb. 20, 2024) – Avation Medical, an innovative neuromodulation and digital health company on a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions, is unveiling its Vivally System to the urology community this week at the 2024 conference of the Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction. Vivally is the first and only non-invasive, FDA-cleared, wearable neuromodulation system for home use that delivers closed-loop, autonomously adjusted electrical stimulation to treat patients with urge urinary incontinence (UUI) and urinary urgency caused by overactive bladder (OAB) syndrome, which affects more than 46 million people in the U.S. A poster highlighting outcomes from Vivally’s REDUCEOAB study demonstrating a statistical difference over sham is being presented by Dr. Colin Goudelocke from Ochsner Medical Center, New Orleans.
Using proprietary algorithms and electromyographical sensors, Vivally detects and automatically calibrates the level of energy being delivered to a patient’s tibial nerve during stimulation to ensure optimal, customized therapeutic output in a true real-time, closed-loop system. Worn on the ankle, Vivally is used by patients at home for therapy sessions lasting only 30 minutes, as little as once per week. Unlike other neuromodulation approaches for bladder treatment, Vivally requires no surgery, drugs, or needles, which is a major advancement in the treatment of UUI and OAB.
In two multi-center clinical trials, the Vivally System was shown to significantly reduce daily void, incontinence, and urgency episodes and improve patient quality of life while facilitating an 89-percent therapy compliance rate. Symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency. The study is featured as the cover story of the current issue of Urology®, the Gold Journal.
“We expect great interest at SUFU, given we are redefining OAB treatment after more than 25 years without true innovation in this area of medicine,” said Avation co-founder and CEO Jill Schiaparelli. “Until now, treatment options have not been patient-centric, with invasive approaches that are expensive, lead to non-compliance, or, worse yet, cause millions of people to simply live with the problem, compromising their ability to participate in daily life.”
The Vivally System is a convenient, next-generation, at-home wearable neuromodulation therapy that is discreet, comfortable, and easy to use. Urology teams collaborate with their patients through online diaries and individualized data to validate, treat, and monitor symptoms for optimal success. Clinicians can increase the number of patients they are able to effectively treat while reducing the cost of care, thus positively impacting both their patients and the economics of their own businesses.
The SUFU conference is the kick-off to the launch of the Vivally System, which will be available next month via a prescription to consumers in select U.S. markets, and then nationally. Clinicians and patients interested in Vivally can contact Avation to learn more at customercare@avation.com.
About Avation Medical and the Vivally System
Avation Medical is an innovative neuromodulation and digital health company with a mission to make wearable peripheral neuromodulation accessible to patients across a variety of clinical conditions. The Company’s Vivally System is the only FDA-cleared, closed-loop, at-home wearable neuromodulation device system. Combined with a companion mobile application, Vivally offers a comprehensive therapy and support system for patients suffering from urge urinary incontinence and urinary urgency caused by overactive bladder syndrome (OAB). Vivally is prescribed by a clinician following a brief clinical evaluation which includes personalized calibration. Personalization establishes an EMG target and range of neuromodulation energy associated with the detection of an EMG signal to indicate nerve activation. Vivally delivers clinically effective therapy in just 30 minutes, as little as once per week. Vivally is available by prescription in select geographies in the United States. Learn more at Avation.com
