The Altaviva™ system: Advanced treatment for urgent bladder leaks

Struggling with the kind of of bladder leaks that happen on the way to the bathroom? Discover a different way to manage urge urinary incontinence (UUI) — and imagine focusing less on leaks and more on what matters to you.

Take the first step

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

More possibilities for treating urge-related bladder leaks

It's time for a device that could change how you manage your urge urinary incontinence. 

What is urge urinary incontinence?

UUI is a type of bladder control problem that can cause a sudden, intense urge to urinate that is difficult to control.1 This may lead to involuntary leakage and frequent, disruptive trips to the bathroom.

What causes UUI?

Bladder and brain communication is essential for bladder control. Communication breakdowns may cause bladder control problems such as urge urinary incontinence.2,3

What are UUI treatment options?

Many people start with lifestyle changes or medications, but these don’t work for everyone and may not provide long-lasting relief. If you are looking for an advanced therapy, talk to your doctor about the Altaviva™ implant.

Take the first step

Fran
Altaviva™ implant patient

How does the Altaviva™ implant work?

The Altaviva™ implant is a small device placed near the ankle that stimulates the tibial nerve — which may help restore communication between the brain and bladder.2,3 For people ready to move beyond medications, the Altaviva™ system may be an option.  

Unlike medications, the Altaviva™ system targets the tibial nerve — not just symptoms. It’s designed with a long-term battery expected to deliver 15 years of therapy,†,4 with infrequent recharging.
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Learn more about the Altaviva™ system, an advanced treatment for urge urinary incontinence. 

Take the first step

†Based on clinical and bench testing for expected therapy settings.

In addition to risks related to surgery, complications can include pain at the implant site, lower leg pain, infection, wound complications, nerve injury, movement of the implant, undesirable change in bowel or bladder function, uncomfortable or unintended stimulation sensations, loss of therapeutic effect, discomfort when recharging, or technical or device problems. Please see Important Safety Information for more details. Talk with your doctor about ways to minimize these risks.

“I can enjoy the moment without worry.”

Living with UUI can feel unpredictable and frustrating. Hear from real patients with urge urinary incontinence.

Anthony and Roschelle's stories may provide hope for many who are battling similar challenges. While their results are uniquely theirs, they inspire a message of hope and potential for others.

Individual results may vary. Talk to your doctor to see if the Altaviva™ system is right for you.

Take the first step

See if the Altaviva™ system may be right for you.

Improved quality of life5 could be a single procedure away with the Altaviva™ therapy

No sedation required
The Altaviva™ bladder control implant for UUI is placed near your ankle with a minimally invasive procedure6 that does not require general anesthesia or sedation.7
Technology for every day
The implant has a long-lasting battery expected to deliver 15 years of therapy,‡,4 and you can walk out the same day with therapy activated.4
Clinical outcomes
In the pivotal clinical trial, after 12 months of therapy 80% of patients reported their condition improved§,6 and 61% of patients had a 50% or greater reduction in UUI episodes.5

‡ Based on clinical and bench testing for expected therapy settings.
§ Adverse events related to the device, procedure, and/or therapy occurred in 20% of implanted subjects through 12-month follow-up. The most common types of related AEs were implant-related infections at the implant site (7%) and implant site pain (3%).

FAQ

Will insurance cover the costs related to the Altaviva™ implant?

Talk to your doctor and your insurance provider to learn more about your coverage.

Will I be able to get an MRI with the implantable device?

You can have a full-body MRI scan if certain conditions are met.8 Your clinician can provide more details about these conditions, as well as safety information.

How long does the Altaviva™ device last?

The implant has a long-lasting battery4 expected to deliver 15 years of therapy.‡
‍‡ Based on clinical and bench testing for expected therapy settings.

Does the Altaviva™ device need to be recharged?

The device only needs to be charged 1–2 times per year under standard therapy settings and charging only takes about 30 minutes with proper placement and default recharge speed.9

What are the risks of the Altaviva™ implant for UUI?

In addition to risks related to surgery, complications can include pain at the implant site, lower leg pain, infection, technical or device problems, movement of the implant, undesirable change in bowel or bladder function, or uncomfortable or unintended stimulation sensations. Please see Important Safety Information for more details. Talk with your doctor about ways to minimize these risks.

How does the Altaviva™ implant work?

Altaviva™ implant works by sending electrical pulses to the tibial nerve, which is linked to the nerves that control your bladder. These pulses may help restore the communication pathway between your brain and bladder,2,3 which may help reduce urgency with leaks.5

Will the Altaviva™ bladder control device cure my UUI?

Urge urinary incontinence is a chronic condition. Altaviva™ therapy can help manage the symptoms but does not cure the condition.

Is the Altaviva™ implant procedure invasive?

The procedure is minimally invasive,6 requiring a 2 cm incision.

What is the Altaviva™ implant for bladder control?

The Altaviva™ implant for UUI involves placing a small device under the skin near your ankle, which sends electrical pulses to the tibial nerve that helps maintain normal bladder function.2,3 These pulses may help restore the communication pathway between your brain and bladder which may help urgency with leaks.5 This treatment is called tibial neuromodulation is a proven therapy for reducing bladder control symptoms.5, 10-14

Why does the Altaviva™ implant target the tibial nerve?

Bladder control issues often stem from miscommunication between the brain and the nerves controlling bladder function.15,16 By targeting the tibial nerve, the therapy may help restore normal bladder function.2,3

1. Abrams P, Cardozo L, Fall M, et al. The standardisation of terminology of lower urinary tract function: Report from the standardisation sub‐committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-178.
2. 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.
3. 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.
4. M028929C001 RevC - Clinician Therapy and Programming Guide Altaviva™ Model P7850N.
5. Appendix B: Clinical Study Summary. M028929C001 RevC - Clinician Therapy and Programming Guide Altaviva™ Model P7850N.
6. Cameron AP, Chung DE, Dielubanza EJ et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder (2024). J Urol. 2024;212:11-20.
7. M028930C001 RevC - Altaviva™ Model P7850N Neurostimulator Implant Manual.
8. M028949C001 RevC - MRI Guidelines for Altaviva™ Neurostimulator.
9. Medtronic data on file: T-Entry System – Recharge Performance Design Verification Test Report.
10. 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.
11. 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.
12. 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.
13. 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.
14. 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.
15. Chancellor MB, Chartier-Kastler EJ. Principles of sacral nerve stimulation (SNS) for the treatment of bladder and urethral sphincter dysfunctions. Neuromod. 2000;3(1):15-26.
16. Leng WW, Chancellor MB. How sacral nerve stimulation neuromodulation works. Urol Clin North Am. 2005;32:11-18.

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.

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Important Safety Information

Medtronic Bladder Control Therapy delivered by the InterStim™ system treats urinary retention (inability to completely empty the bladder) and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency. 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 intended for patients with a urinary blockage.  

Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins.

Medtronic Bowel Control Therapy delivered by InterStim™ system treats chronic fecal incontinence (an accident or leaking involving stool).  It should be used after you have tried other treatments such as medications and dietary modifications and they have not worked, or if you are not a candidate for them.

Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 18; or for patients with progressive, systemic neurological diseases.

Medtronic Bladder Control Therapy and Medtronic Bowel Control Therapy: You must demonstrate an appropriate response to the evaluation to be a candidate. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim™ device

In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead (thin wire) movement/migration, device problems, interactions with certain other devices or diagnostic equipment such as MRI, undesirable changes in urinary or bowel function, and uncomfortable stimulation (sometimes described as a jolting or shocking feeling).

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 further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronic’s website at www.medtronic.com.

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