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BLADDER & BOWEL SOLUTIONS

Implantable tibial neuromodulation (ITNM)

Elevate your treatment options with the Altaviva™ system, a minimally invasive¹ option for urge urinary incontinence (UUI).

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Indications, Safety, and WarningsIndications for useTibial Neuromodulation delivered by the Altaviva™ system is indicated for treatment of urge urinary incontinence (UUI) in patients who failed or could not tolerate more conservative treatments.ContraindicationsPoor surgical candidates including patients with skin lesions or compromised skin integrity; current or recent history of venous insufficiency and/or venous stasis ulcers in the lower leg; anatomical defects or previous surgeries at the implant site which preclude use of the device. Patients who are not able to operate or receive assistance in operating the system. WarningsThis therapy is not intended for patients who are considered poor candidates for surgery or are at risk for poor wound healing including, but not limited to, severe uncontrolled diabetes, clinically significant edema in the lower leg, clinically significant peripheral neuropathy, nerve damage, or a neurological condition affecting the lower leg. Do not implant the neurostimulator within 5 cm of another metal implant. This therapy is also not intended for patients with current or unresolved mechanical obstruction such as caused by benign prostatic hypertrophy, cancer, or urethral strictures, or patients with known allergies to any of the materials in the Altaviva™ neurostimulator. Continuous stimulation should not be used as safety and effectiveness have not been established. Safety and effectiveness have also not been established for pregnant women; patients under the age of 18; patients with progressive, systemic neurologic disease; patients with history of urinary retention; bilateral leg stimulation. Diathermy (shortwave and microwave) should not be used on patients with a neurostimulator, as it can cause tissue damage or device damage. The Altaviva™ system may affect the operation of other implanted or external systems. The Altaviva™ system may interfere with the operation of other implanted cardiac devices such as pacemakers and defibrillators. Recharging the neurostimulator within 5 cm of a metal implant may cause recharge heating leading to tissue damage. Do not use the recharger or ankle band in direct contact with an unhealed wound. MRI WarningsPrior to an MRI scan, determine if the patient has multiple active or abandoned medical device implants. The most restrictive MRI exposure requirement must be used. MRI scans with another metal implant less than 3 cm away from the Altaviva™ neurostimulator have not been tested, and scanning may cause excessive tissue heating surrounding the device resulting in tissue damage and possible need for surgical intervention.Adverse EventsIn addition to the risks normally associated with surgery, adverse events may include pain at the implant site, infection, reaction to local anesthesia, wound complications, lower leg pain, nerve injury, movement of the implant, adverse change in bowel or urinary function, uncomfortable or unintended stimulation sensations or an inappropriate shock sensation, loss of therapeutic effect, discomfort during recharge, or technical or device problems. For full prescribing information, refer to the product manuals at www.medtronic.com. Product manuals must be reviewed prior to use for detailed disclosure. USA Rx Only. Rev 0925

Less restroom.^†,2 More YES room.

Individual results may vary.

† Less restroom is based on patient reported outcomes using the OAB-q, which measures how bladder symptoms affect daily life. Results reﬂect how patients felt about restroom use and related frustrations, not a direct measurement of restroom visits.

A simple option for you and your patients with UUI

Single procedure³

Automatic therapy delivery⁴

Long-lasting device with expected 15-years of therapy^‡,4

Minimally invasive procedure¹ designed to fit into your practice’s existing workflow

Approved for urgency with leaks

How it works

The Altaviva™ device can be placed using the Medtronic pocket dissector^§ above the fascia near the ankle.
With no sedation or imaging³ required, the device is placed with a small, 2 cm incision³ along the Langer lines.
Same-day therapy activation⁴ delivers stimulation on a schedule to the tibial nerve, helping improve UUI symptoms.⁵

In addition to risks related to surgery, complications can include pain at the implant site, infection, reaction to local anesthesia, wound complications, lower leg pain, nerve injury, movement of the implant, adverse change in bowel or urinary function, uncomfortable or unintended stimulation sensations, loss of therapeutic effect, discomfort during recharge, or technical or device problems. Please refer to Important Safety Information for more details

§ Surgical instrument is recommended for use, but not required. Sold separately.

Empowering choices.
Expanding access.

The Altaviva™ system is a minimally invasive procedure¹ that enables you to treat more patients while providing an option that may help improve their quality of life.⁵

Medtronic has the most extensive neuromodulation portfolio for bladder and bowel control available, allowing you and your patients to explore options together, for shared decision making.

A simple experience

No sedation or imaging required³

Same day therapy activation⁴

MRI-ready from the start⁶

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Altaviva™ system for UUI gives your patient access to tibial neuromodulation, a proven therapy for bladder control^5,7-10

After 12 months of Altaviva™ therapy:

80%

reported their condition had improved^¶ compared to before their implant.⁵

70%

of patients experienced a clinically meaningful^# improvement in health-related quality of life.⁵

61%

of patients had at least 50% reduction in UUI episodes after 12 months of therapy.⁵

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%).

¶ As assessed by the Patient Global Impression of Improvement.

# Minimally Important Difference (MID) = 10 points

Adena is a patient with overactive bladder and was part of the Altaviva™ clinical trial. Used for promotional purposes. This patient participated in the TITAN 2 clinical trial that
studied the investigational tibial neuromodulation device and its use. For more information, visit clinicaltrials.gov: NCT05226286.

“I used to feel trapped. I couldn’t go anywhere without worrying about accidents. Now I can go to the grocery store, travel, and enjoy life again.”

Individual results may vary.

Adeana, living with UUI.

“It’s a boost of confidence... I’m not worried about embarrassing myself somewhere, or always having to carry pads with me.”

Individual results may vary.

Frances, living with UUI.

This patient participated in the TITAN 2 clinical trial that studied the investigational tibial neuromodulation device and its use. For more information, visit clinicaltrials.gov: NCT05226286.

Technology for every day

MRI compatibility:

Backed by 20 years of research provides your patient with full body^◊ MRI compatability.

Overdrive™ battery technology:

Our Overdrive™ technology prevents battery degradation over time. This means your patients can expect the same recharge performance in year 15 as in year one.^11-13

Support beyond the product:

Comprehensive education, digital diaries, and reporting using the Medtronic Mobile App

Medtronic customer team helps answer patient questions

Patient access connect team supports you and your staff with prior authorization

Discover why the Altaviva™ system is different — only with Medtronic

Submit a request form to connect with a local representative. Expand treatment options and inspire confidence and optimism by offering patients a renewed sense of hope.

Reimbursement

Learn more about the resources that Medtronic has to support you with navigating the reimbursement process including coding, prior authorization, and claims denials.

Prior authorization support

The Medtronic Patient Access Support (PAS) program helps facilitate patient access to Medtronic therapies by providing prior authorization support to healthcare providers upon request. This program is available to support patient access to the pelvic health therapies.

For inquiries, please contact Medtronic

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Frequently asked questions

The Altaviva™ implant uses implantable tibial neuromodulation (ITNM), a proven therapy for reducing bladder control symptoms^5,7-10 by addressing the underlying neural communication issues.

The device is placed under the skin near the ankle and stimulates the tibial nerve. This may help restore the communication pathway between the brain and bladder,^14-15 which may help reduce urgency urinary incontinence.⁵

Bladder control issues are believed to stem from miscommunication between the brain and the nerves controlling bladder function. By targeting the tibial nerve, the implantable tibial neuromodulation therapy may help to restore normal bladder function.^14,15

The device only needs to be recharged 1–2 times per year under standard therapy settings, with each session taking about 30 minutes when properly positioned.¹⁶

UUI is a chronic condition. Altaviva™ therapy may help manage symptoms effectively, but does not cure the condition.

The Altaviva™ device is expected to be a long-lasting device, with up to 15 years of therapy.⁴

The procedure is minimally invasive,¹ requiring a 2 cm incision. No sedation or radiology is required for placement.³

Yes, patients can have full-body MRI scans if specific conditions are met.⁶ We can provide detailed safety information to guide you and your patients.

We recommend discussing coverage directly with the patient’s insurance provider. We are happy to support you with prior authorization if needed.

Physicians or patients can contact us for more information. Prospective patients can reach an education specialist at (800) 664-5111, and existing patients can contact a service specialist at (800) 510-6735.

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

§ Surgical instrument is recommended for use, but not required. Sold separately.

◊ Under certain conditions; see approved labeling for details.

¶ As assessed by the Patient Global Impression of Improvement.

# Minimally Important Difference (MID) = 10 points

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.
VV-TMF-841603 Statistical Report 29 Apr 2025(v1.0).
M028930C001RevC- Altaviva™ Model P7850N Neurostimulator Implant Manual.
M028929C001RevC- Clinician Therapy and Programming Guide Altaviva™ Model P7850N
Appendix B: Clinical Study Summary. M028929C001 RevC - Clinician Therapy and Programming Guide Altaviva™ Model P7850N.
M028949C001 RevC MRI Guidelines for Altaviva™ Neurostimulator.
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.
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.
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.
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.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.
M971262A001 RevG - Engineering Bill of Materials InterStim Micro.
M019324C001 - Bill of Materials Report for P7850N.
M985332A - InterStim Micro Rechargeable Battery Assembly.
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.
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.
Medtronic data on file: T-Entry System – Recharge Performance Design Verification Test

Implantable tibial neuromodulation (ITNM)

Less restroom.^†,2 More YES room.