Medtronic Altaviva™ tibial neuromodulation system treats urge urinary incontinence (leakage). It should be used after you have tried other treatments such as medications and behavioral therapy, and they have not worked or you could not tolerate them.

This therapy is not for everyone. The Altaviva™ system is contraindicated (not allowed) for patients who are poor surgical candidates including patients with open wounds, sores, or damaged skin near the treatment area; current or recent history of poor blood circulation in the legs or open sores on the legs from circulation problems; physical changes or previous surgeries where the Altaviva™ device is placed. You must be able to operate or receive assistance in operating the system to be a candidate. 

This therapy is not intended for patients who: are not good candidates for surgery or have conditions that make it hard to heal from wounds (such as uncontrolled diabetes, swelling in the lower leg, or nerve problems in the leg); have metal implanted within 5 cm of where the Altaviva™ device would be placed; have a current or unresolved blockage in the urinary tract caused by things like an enlarged prostate, cancer, or urethral narrowing; are allergic to any materials in the Altaviva™ device. The Altaviva™ system may affect or be affected by other implanted medical devices, including pacemakers and defibrillators. Talk to your doctor if you have a pacemaker or other implanted devices. You cannot have diathermy (deep heat treatment using shortwave or microwave electromagnetic energy) if you have an Altaviva™ device. Do not place the charger or ankle band on broken or unhealed skin. Safety and effectiveness have not been established for pregnancy; patients under the age of 18; patients with progressive, systemic neurologic disease; patients with history of urinary retention, or bilateral stimulation.

In addition to risks related to surgery, complications can include pain at the implant site or lower leg pain, infection, wound complications, nerve injury, movement of the implant, undesirable change in bowel or bladder function, uncomfortable or unintended stimulation sensations, unexpected shocking sensation, loss of therapeutic effect, discomfort when recharging, or technical or device problems.

This therapy is not for everyone. This treatment is prescribed by your doctor. Please talk to your doctor to decide whether this therapy is right for you. Your doctor should discuss all potential benefits and risks with you. Although many patients may benefit from the use of this treatment, results may vary.

For complete safety information about this treatment, please visit the Medtronic website at www.medtronic.com.

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