Michael Barbella, Managing Editor04.17.24
Avation Medical has unveiled the Vivally System, a U.S. Food and Drug Administration (FDA)-cleared, wearable neuromodulation system for home use that delivers closed-loop, autonomously adjusted electrical stimulation to treat urge urinary incontinence (UUI) and urinary urgency caused by overactive bladder (OAB) syndrome. The condition affects more than 46 million people in the United States.
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 real-time, closed-loop system. Worn on the ankle, Vivally is used by patients at home for therapy sessions lasting 30 minutes, as little as once per week. Unlike other neuromodulation approaches for bladder treatment, Vivally requires no surgery, drugs, or needles.
In two multi-center clinical trials, the Vivally System significantly reduced daily void, incontinence, and urgency episodes and improved patient quality of life while facilitating an 89% therapy compliance rate. Symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency.
“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,” Avation Co-Founder/CEO Jill Schiaparelli said. “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 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.
Avation Medical is a neuromodulation and digital health company aattempting to make wearable peripheral neuromodulation accessible to patients across various clinical conditions. The company claims its Vivally System is the only FDA-cleared, closed-loop, at-home wearable neuromodulation device system. 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 is available by prescription in select geographies in the United States.
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 real-time, closed-loop system. Worn on the ankle, Vivally is used by patients at home for therapy sessions lasting 30 minutes, as little as once per week. Unlike other neuromodulation approaches for bladder treatment, Vivally requires no surgery, drugs, or needles.
In two multi-center clinical trials, the Vivally System significantly reduced daily void, incontinence, and urgency episodes and improved patient quality of life while facilitating an 89% therapy compliance rate. Symptom reduction was demonstrated out to one year, even with a decrease in therapy frequency.
“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,” Avation Co-Founder/CEO Jill Schiaparelli said. “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 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.
Avation Medical is a neuromodulation and digital health company aattempting to make wearable peripheral neuromodulation accessible to patients across various clinical conditions. The company claims its Vivally System is the only FDA-cleared, closed-loop, at-home wearable neuromodulation device system. 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 is available by prescription in select geographies in the United States.