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From now on you decide if it’s go time… or not.
A breakthrough in the treatment of overactive bladder (OAB) and urge urinary incontinence (UUI). Vivally® is a patient-friendly, drug, needle, and surgery free at-home therapy and digital behavioral health support system for OAB and UUI.
Vivally provides the tools to get you back to doing the things you love.
Managed by the Vivally App on your mobile device, Vivally Therapy is comprised of a comfortable ankle Garment powered by an intelligent Controller that provides personalized neuromodulation energy to the tibial nerve. Featuring SMART Sense™ technology that uses your unique response to energy that confirms and continuously adjusts therapy parameters to ensure optimal therapeutic output.
Your Vivally Diary enhances your Vivally Therapy by providing behavioral support and insights to enhance therapy outcomes. The Diary helps you keep track of your activity and progress towards prescribed goals. Maintaining a diary of your behavior and symptoms helps to connect you with your clinician to illustrate how your prescribed therapy is positively impacting your condition.
Neuromodulation therapies help re-establish normal body function through electrical energy delivered to your nerve pathways. Neuromodulation is believed to stimulate the afferent nerve fibers of a nerve pathway, modulating the brain’s influence over involuntary actions of the body. In the case of overactive bladder, commonly referred to as OAB, neuromodulation is thought to modify the brain’s influence over the detrusor muscle of the bladder. Put simply, neuromodulation therapies can help reestablish normal body function, like the way a cardiac pacemaker can correct issues with heartbeat rhythm. Over the past two decades neuromodulation has positively impacted the clinical management of OAB and is now well established as a safe and effective treatment for OAB.
Multiple nerve-brain pathways have been described as effective for neuromodulation of OAB including the sacral spinal nerve, the pudendal nerve, and the tibial nerve. Vivally targets the tibial nerve as we believe it is the safest and most effective nerve pathway in the body. Next-generation neuromodulation therapy, like the Vivally System, provides a patient-friendly treatment option due to its non-invasive approach, ease of use, convenience, comfort, and positive clinical outcomes.
The Vivally System is currently seeking an FDA indication to treat the symptoms of overactive bladder (OAB) and urge urinary incontinence (UUI), conditions that affect an estimated 42 million people in the United States. While still an investigational device, data on the Vivally System was presented at the Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) as well as the American Urogynecologic Society (AUGS) scientific meetings. This data, from a multi-center study of 96 subjects with OAB demonstrated an 84.8% global responder rate at 12 weeks with no serious adverse events.
— Jill Schiaparelli Avation CEO
Caution: Investigational Device. Limited by Federal Law to Investigational Use Only.
