Frequently Asked Questions

Overactive Bladder (OAB) is a condition with a sudden urge to urinate, frequent bathroom visits, urinary incontinence (or leakage) or nocturia.

OAB is a common condition affecting over 16% of adults (nearly 45 million people in the US) and can severely impact patients’ quality of life.

Some existing treatments include behavioral modifications, pelvic exercise, drugs, BOTOX, percutaneous tibial nerve stimulation (PTNS) or sacral or tibial surgical implants.

Most existing treatments are invasive, costly, have severe side-effects, need surgery or needles and are disruptive to daily life. In contrast, Vivally is a wearable, at-home, comfortable and proven therapy for OAB that gives patients control over their treatment.

Our clinical data demonstrated that patients using Vivally had significant improvements in voiding (frequency of bathroom visits), incontinence (leaks), urgency, nocturia (sleep interruption) and usage of incontinence pads.

Vivally is a great option for patients seeking non-invasive, drug-free, easy-to-use at-home treatment therapy. Vivally works for broad populations with very few contraindications as listed in the Vivally User Guide. Please consult your healthcare provider about the suitability of Vivally for your conditions.

Vivally is a non-invasive wearable tibial neuromodulation device with a user-friendly mobile app. It is designed for home-use and provides patients control over their own therapy.

Vivally uses the principle of neuromodulation, which has found broad applications in healthcare in recent years. When you wear the garment, the built-in electrodes send gentle electrical pulses to the tibial nerve in your ankle. This signal affects and restores the bladder and brain communication, which in turn controls the detrusor muscle contractions and urinary symptoms.

Vivally was created with patients at front and center. Its novel features include a simple-to-wear garment that works for both feet, reusable gel cushions, rechargeable battery, a user-friendly app and digital cloud database. Vivally proprietary bi-phasic stimulation waveform ensures maximum comfort and optimal therapy outcomes. These innovations, including our novel closed-loop control technology, are enshrined through our strong intellectual property containing well over 100 patents in the US and globally.

Our unique and proprietary closed-loop control monitors body’s muscular response (EMG) to stimulation and automatically adjusts the stimulation output to ensure optimal therapy. This is done multiple times in a second, thus allowing patients freedom of movement and carefree therapy, at-home and with minimal clinical supervision.

Vivally System was cleared by FDA (Food and Drug Administration) through rigorous 510(k) process, ref K220454, which entailed extensive device testing under harsh environments. Additionally, Vivally has been subject to multiple clinical trials and regulatory compliance audits (see details in later sections).

As a durable medical equipment (DME), Vivally durability has been ascertained for at least three years. Real time and accelerated testing have demonstrated lifespan well beyond the claimed 3 years.

Vivally app on your smartphone (iOS or Android) gives you more control over therapy. You can also track your OAB symptoms and behavioral changes in the app. The app collects critical data from your Vivally system and stores it in cloud so that your clinician and our trained staff can monitor your therapy and device use.

Vivally is designed to be largely maintenance-free and easy to use. You just need to periodically charge the device (charger is provided) and replace the gel cushions every month, which Avation Medical supplies. The garment may need occasional cleaning depending on usage. All software upgrades are at no cost to users.

Vivally System has been extensively tested through multiple clinical trials to assess efficacy, safety and usability. In our 125-patient sham-controlled trial, the effectiveness for primary symptoms of leaks or voids was noted at 84%, with 49% patients becoming asymptomatic in one or more symptom after 12 weeks of Vivally use. Another 96-patient study demonstrated long-term benefits over 1 year. Additionally, Vivally was subject to numerous feasibility and human factors studies.

In these studies, 99% patients were satisfied and found the device easy to use. The quality of life improved by over 2 times of what is statistically needed. Finally, no device-related serious adverse events were reported.

Yes! Using Vivally is simple. Just wear the garment around your ankle, place the controller in the garment and press Start in the app. All you need is three 30-minute sessions per week, anytime, anywhere. Avation Medical will help with your one-time setup including getting the app on your phone and bluetooth pairing.

Majority of our clinical outcomes are reported after 12 weeks of use. However, most patients start seeing changes in 4 weeks or sooner. Outcomes depend on device usage and both Avation Medical and your clinician can help optimize therapy based on your symptom improvements.

Vivally is designed to provide personalized therapy to each patient. A one-time calibration helps determine the best stimulation parameters for you and this information stays with you, even when you are traveling or need to use a different phone. Calibration can be done by your clinician or trained Avation Medical staff.

We recommend at least 3 sessions per week in early days, since this reflects our clinical trial usage. Therapy schedule can be changed by you or by your clinician based on symptom improvements. Each session is 30 minutes long and you can do your normal daily activities during the therapy.

Vivally is inherently safe with non-significant risk per device designation. Our clinical trials showed no serious adverse effects attributed to Vivally. If the stimulation is set too high or if the electrode interface is damaged, the stimulation can feel too strong or cause some temporary skin irritation. There are no known side effects from Vivally usage.

Please fill a simple 1-page prescription which can be done online or via email/fax. Insurance cases will also need the patients’ medical records to demonstrate medical necessity.

Talk with your clinician to see if Vivally is right for your symptoms. Once confirmed, the clinician will send a simple 1-page Rx to Avation Medical to start the order process.

After the prescription, fill out order forms and agreements (can be done online or through email/fax). We are here to assist you with each step, and we also work directly with clinicians to get any medical records as needed.

Presently, Vivally is available in the US market in majority of states. Avation Medical can also help you find a clinician in your area to prescribe Vivally.

Avation Medical directly works with insurance companies for filing claims and billing. We are working with all major payors for insurance processing and reimbursement.

Yes, we have successfully supplied Vivally and helped veterans across the country. We work directly with the VA clinical and purchasing staff, as well as patients to ensure veterans have access to Vivally therapy.

We are committed to ensure widest possible Vivally availability and affordability. If your insurance does not cover Vivally (e.g. insurance is denied or of you have Medicare Part A), Avation Medical is offering a self-pay option with early adoption discount, in additional to financial assistance programs based on eligibility. We will work with you on exploring these alternatives.

Yes, Avation Medical offers a 1-year warranty on all durable parts against any manufacturing defects. Furthermore, Avation Medical offers a simple return with full refund for a pre-defined period, in case you are not satisfied with the device or have other reasons to discontinue. Please review our return and warranty policies on the Avation Medical website.

Avation Medical was founded on the principles of helping the patients restore their quality of life, simplifying the healthcare ecosystem and providing clinicians with a novel non-invasive option to offer to their patients.

Avation Medical is registered with FDA and certified to ISO13485. Furthermore, Avation Medical has been extensively audited by various state, national and federal regulatory agencies including the FDA. Vivally is manufactured in the USA under highest quality standards and delivered from our facilities in Valencia, CA.

Your information and privacy is very important to us. Avation Medical handles your information in strict compliance with FDA requirements and other federal laws, such as in a secure HIPAA compliant cloud database. Please review our Privacy policy on the Avation Medical website.

The Avation Medical website contains helpful information and links, including Vivally technology, clinical data, prescription etc. Additionally Vivally app includes numerous support options, detailed instructions for use and help videos. Finally, you can contact us at customercare@avation.com or call 888-972-5694 for any assistance.