Altaviva™ Therapy

Discover Altaviva™ therapy

The Altaviva™ implant is your convenient and hopeful next step, with automatic therapy delivery that  can integrate seamlessly into your life—designed to keep you moving forward, wherever your

journey leads. Unlike medications or injections that target bladder muscles, the Altaviva™ implant  for urge urinary incontinence (UUI) targets the tibial nerve that helps control normal bladder  function.^1,2

How does it work?

• A small device is placed under the skin near the ankle and sends electrical pulses to the tibial nerve that is important in maintaining normal bladder function.^1,2
• These pulses may help restore the communication pathways between the bladder and brain,^1,2 which may help reduce urgency with leaks.³
• This treatment is called tibial neuromodulation, a proven therapy for reducing bladder control symptoms.^3,4-8

A single procedure may help improve your quality of life:

• Implanted in a single, outpatient procedure that lets you go home the same day
• Same-day therapy activation9
• MRI-ready from the start for full-body 1.5T or 3T scans*,¹⁰
• Long-lasting battery – designed to deliver up to 15 years of treatment†

For more information, visit www.Medtronic.com/Altaviva

In addition to risks related to surgery, complications can include pain at the implant site, lower leg  pain, infection, and/or technical or device problems. Results vary. Talk to your doctor to see if the  Altaviva™ system is right for you.

*MRI compatibility is subject to certain conditions. See approved labeling for details.

† Based on clinical and bench testing for expected therapy settings

1. Li X, Li X, Liao L. Mechanism of action of tibial nerve stimulation in the treatment of lower urinary tract  dysfunction. Neuromod. 2023;27:256–266.

2. Bhide AA, Tailor V, Fernando R, Vik K, Digesu GA. Posterior tibial nerve stimulation for overactive bladder –  techniques and efficacy. Int Urogynecol J. 2020;31:865–70.

3. Appendix B: Clinical Study Summary. M028929C001 RevC – Clinician Therapy and Programming Guide Altaviva™ Model P7850N.

4. Peters KM, Carrico DJ, et al. Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in  the treatment of overactive bladder syndrome: results from the SUmiT trial. J Urol. 2010;183:1438–1443.

5. Peters KM, MacDiarmid SA, Wooldridge LS, et al. Randomized trial of percutaneous tibial nerve stimulation  versus extended-release tolterodine: results from the overactive bladder innovative therapy trial. J Urol.2009;182(3):1055–1061.

6. Kobashi K, Nitti V, Margolis E, et al. A prospective study to evaluate efficacy using the NURO percutaneous tibial  neuromodulation system in drug-naïve patients with overactive bladder syndrome. J Urol. 2019;131:77–82.

7. Rogers A, Bragg S, Ferrante K, et al. Pivotal study of leadless tibial nerve stimulation with eCoin for urgency  urinary incontinence: an open-label, single arm trial. J Urol. 2021;206:399–408.

8. Heesakkers JPFA, Toozs-Hobson P, Sutherland SE, et al. A prospective study to assess the effectiveness and  safety of the BlueWind system in the treatment of patients diagnosed with urgency urinary incontinence.  Neurourol Urodyn. 2024;43:1491–1503.

9. M028930C001 RevC – Altaviva™ Model P7850N Neurostimulator Implant Manual.

10. M028949C001 RevC – MRI Guidelines for Altaviva™ Neurostimulator

Important Safety Information

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.