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The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

The Revi™ System is an implanted tibial electrical urinary continence device that wirelessly receives power from a non-implanted external wearable unit to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of urge urinary incontinence, alone or in combination with urinary urgency. The implantable device is implanted in the vicinity of the tibial neurovascular bundle. The treatment effect of the system is achieved by the implantable wireless neurostimulation component, which sends pulses to the tibial nerve when energized by the wearable unit transmitted power. The electrical pulses stimulate the nerve along the leg, reaching the sacral plexus and entering the spinal cord. This stimulation has the power to modulate nerve function, relieving symptoms.

The Revi System is indicated for the treatment of patients with symptoms of urgency incontinence alone or in combination with urinary urgency.

The Revi System is a tibial neuromodulation system that consists of the following four different components: 1. Implant: An implantable wireless neurostimulation component that is implanted in the vicinity of the tibial neurovascular bundle. The implant is battery-less and does not have an internal power source. 2. Rechargeable Wearable Unit: This unit is comprised of a wearable device and leg band. The wearable device contains an electrical circuit board, flexible antenna, and rechargeable battery with dedicated charger. The Rechargeable Wearable Unit, when used by the patient, is designed to be paired to a specific implant. Once paired, the Rechargeable Wearable Device transmits power and can only communicate (through magnetic coupling) with the specific implant to which it is paired. 3. Clinician Programmer (CP): This application is the system's interface used by the healthcare providers for treatment control, status evaluation, parameter programming and data acquisition. Access to the CP is password protected to allow access only to authorized users. The CP transfers data to and from the Rechargeable Wearable Unit via a wireless Bluetooth connection. 4. HealthGo Micro (Hub): The Hub communicates with the Rechargeable Wearable Unit using a Bluetooth connection and acquires and transmits data to the Cloud only during the charging sessions of the Rechargeable Unit. The Hub allows health care providers access to device data logs between visits without the need for in-person visits. The Hub is a Class I 510(k) exempt device (Product code OUG, 21 CFR 880.6310).