The Vivally System by Avation Medical is an FDA-cleared (510(k) K220454) wearable neuromodulation device that treats overactive bladder (OAB) using closed-loop transcutaneous tibial nerve stimulation. It is worn on the lower leg for 30 minutes, 3 times per week, and automatically adjusts stimulation based on real-time EMG feedback. The system includes the Vivally Wrap, CliQ Stimulator, and Vivally App. Key features include an ergonomic wearable garment that works on both feet, rechargeable battery, reusable gel cushions, and a proprietary stimulation waveform for maximum comfort and effectiveness.
Clinicians prescribe Vivally with a 1-page Rx form and chart notes. Calibration can be done in-person or remotely. Clinicians can monitor patient compliance and symptoms through the clinical portal. Potential CPT codes include 99203 (office visit) and 98980 (Remote Therapeutic Monitoring, monthly).
What is Vivally®?
A new revolutionary option for overactive bladder: non-invasive, at-home therapy with wearable neuromodulation and unique closed-loop control. Vivally® is FDA-cleared and designed as a long-lasting device you can use on your schedule.
- Non-invasive
- At-home therapy
- Wearable neuromodulation
- Unique closed-loop control
- FDA-cleared
- Long-lasting device
How Vivally® Works
Vivally® applies electrical pulses to the tibial nerve to affect brain–bladder communication, helping control detrusor muscle contraction. Real-time feedback helps adjust and optimize therapy.
- Apply electrical pulses to the tibial nerve
- Affect brain–bladder communication
- Help control detrusor muscle contraction
- Use feedback to adjust and optimize therapy
“I love that Vivally® is on my schedule—I can complete the 30-minute sessions when it works for me.”
“It's easy enough to do two to three times a week to tackle my OAB.”
“The Vivally® System is easy-to-use, non-invasive, and doesn't interfere with daily life.”
“I can't imagine why anyone wouldn't want to use the Vivally® System.”
“Vivally® beats the heck out of another pill or the needle therapy that was prescribed.”
Flexible therapy when and where you want. Wear Vivally® while folding laundry or while in the carpool line. Start therapy when doing dishes or kicking up your feet and watching TV. Just 30 minutes, 3 times a week is all it takes.
Personalized just for you. Vivally® leverages true physiologic closed-loop control to personalize and optimize therapeutic output based on your individual needs.
Indications for Use:
The Vivally® System is a wearable neuromodulation system to treat patients with the bladder conditions of urge urinary incontinence and urinary urgency.
We're here for you.
Need a prescription? Or want to find a provider? Whether you are just getting started or have a question about the Vivally System along your journey, our Customer Care Team is here to ensure you have the best possible experience with Vivally.
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