Altaviva™ Tibial Implant Is Reshaping UUI Therapy

Sponsored by Medtronic

Expanding UUI Treatment Access with the Altaviva™ device

Urgency urinary incontinence (UUI) represents a significant burden for patients and the healthcare system. Affecting ~16 million adults^1,2, UUI is the sudden need to urinate coupled with involuntary leakage³. Despite its prevalence and often significant impact on quality of life^1,2, UUI remains markedly undertreated^3,4. A combination of patient hesitancy, lack of screening, and limitations in existing therapy options all contribute to a substantial unmet clinical need. The Altaviva™ tibial implant offers a promising opportunity to address these barriers and expand access to UUI care.

UUI Clinical Need

The current UUI landscape is stymied due to significant underdiagnosis, prolonged delays in treatment timelines, and high attrition rates even amongst fellowship-trained pelvic floor surgeons. Although millions are affected, only 26% of patients report discussing their symptoms with a healthcare professional⁵. Compounding this issue, most patients who had never discussed their problems with a healthcare professional said they had not been asked about OAB symptoms by their provider⁶. This underscores the observation that many healthcare professionals don’t routinely inquire about OAB symptoms, leaving many unaddressed. On average, patients wait approximately three years before seeking care⁶, often due to embarrassment, stigma, or the misconception that symptoms are a normal part of aging with no viable treatments beyond expensive and polluting adult incontinence products.

If patients finally connect with a pelvic floor healthcare professional, engagement remains a massive challenge. This attrition reflects both dissatisfaction with available treatments and the burden associated with ongoing care. Beyond the 82% of patients who fail an OAB medication due to side effects/cognitive risk of anticholinergics, lack of efficacy and/or high cost of beta agonists⁷, few progress to advanced therapies⁴. Initial access to and chronic maintenance of traditional advanced therapies remains dismal^3,4. Botox treatments have high discontinuation rates (in one study, 67% of patients discontinued after one treatment⁸, and another study showed that 75% discontinued after two treatments⁹) with increased insurance headwinds¹⁰. Conversely, only 19% of percutaneous tibial neuromodulation (PTNM) patients in one study continued treatments after the first year due to burden of treatments and/or coverage challenges¹¹. Sacral neuromodulation (SNM) can be effective, but it is often perceived as more invasive with multiple stages requiring sedative/general anesthesia and it has the steepest learning curve. In summary, a vast 64% of individuals with OAB are not being treated⁵, underscoring the magnitude of unmet need.

These limitations highlight the need for a less burdensome treatment that helps more patients over time. In my own practice, I have patients who have transitioned to the Altaviva™ therapy due to beta-3 adrenergic agonists not working well enough or being too expensive, Botox injection fatigue, a strong desire to avoid an SNM surgery even after a successful percutaneous nerve evaluation (PNE) trial, and prior non-invasive tibial neuromodulation therapy responders who desired an implanted automated option.

Reducing Barriers with the Altaviva™ device

The Altaviva™ implantable tibial neuromodulation device represents an alternative approach to neuromodulation therapy. Since the procedure can be performed with just local anesthetic, a diverse range of patients can be treated by many pelvic floor surgeons in a latitude of service sites.This small device is placed subcutaneously above the fascia using a ~2 cm incision thoughtfully along Langer’s lines. The Altaviva™ device has a small incision which is significant considering the reduced blood flow in the lower leg.

The device can be placed with a recommended pocket dissector tool which facilitates placement of the implant on top of the fascia above the tibial nerve. While not required, this separate surgical instrument uses a backstop to create a subcutaneous pocket that accommodates the size of the Altaviva™ device.

The Altaviva™ device’s leadless design streamlines implantation and has a generous stimulation field¹². In my practice, I see successful nerve stim every time, which is aligned with what was observed in the clinical trial¹³. It is the only FDA-approved tibial implant with same-day activation which allows for immediate initiation of therapy. The Altaviva™ device is also the only FDA-approved subcutaneous tibial implant with a medical-grade battery which has a lifespan of 15 years, greatly extending the timeframe for device exchange in a more tenuous anatomical space. Its 15-year battery life is aligned with the primary cell standard seen in SNM since 2022.

The device fully recharges in under 30 minutes with proper placement and default charge speed. Typically, recharging is required only once or twice a year under standard settings. The overdrive technology prevents battery fade with recharging. The other subcutaneous implant is a primary cell battery with just a 3-year average battery life¹⁴, potentially necessitating costly exchanges at a much faster cadence. I anticipate that exchanging the Altaviva™ device will be straightforward with only needing to incise the ~2 cm proximal capsule with preserved offsetting of the device from the closure.

The Altaviva™ device is the only subcutaneous tibial implant with customizable programming and automatic therapy activation without having to return to the clinic. Patients can make some programming adjustments themselves, and their provider or company representative can help them remotely in this process. The other subcutaneous implant can only be activated in person by a company representative after weeks of healing with one set algorithm of dosing beyond adjusting amplitude level¹⁵. I have some patients for whom a subcutaneous implant is the right choice, but they need therapy more than a couple of times a week; the Altaviva™ implant is an important option for these patients, with its flexibility to deliver more frequent stimulation. My first commercial implant was a patient who previously had another subcutaneous device but lacked symptom control with every 4^th day 30-minute stimulation. She waited 2 years for another option to become available that would better suit her needs. When the Altaviva™ device was approved, its ability to deliver stimulation more frequently made it a better fit for her.

With approximately 40 million MRI scans performed annually in the US¹⁶, superior MRI compatibility is critical and expected in 2026. The Altaviva™ device is the only implantable tibial neuromodulation device that is full-body MRI ready from the start, requiring no device interaction even if actively stimulating. The other subcutaneous implant needs to remain 20 cm from the edge of the scanner bore; considering that the target anatomy should be at the isocenter of the bore for optimal imaging, this means that in practice the area of the body being imaged must be several feet above the tibial implant. Such constraints create significant conundrums such as avoiding needed imaging or needing to remove a tibial implant to permit imaging. The ability to avoid these scenarios completely is best and opens up the option for implantable tibial neuromodulation in more patients.

Initial Clinical Evidence as a Strong Starting Point

The TITAN 2 study¹⁷ was intentionally designed to reflect a refractory UUI population. The study included individuals who had failed and/or were intolerant to at least two medications¹⁷. In addition, 29% had previously tried an advanced therapy¹². Participants had severe symptom burden with a baseline average of 5.1 UUI episodes per day. At 12 months, the therapy achieved a responder rate of 61%¹⁷, with sustained improvements observed at 24 months¹⁸. The 100% UUI resolution rate of 22% at 12 months¹⁷ is comparable to other advanced therapies. Notably, 80% of patients reported subjective improvement in their condition, and 76% indicated they would recommend the therapy to others. The safety profile was favorable with expected adverse events despite it being a novel device and procedure. Through 12 months, 20% of patients had an adverse event related to the device, procedure, or therapy, all of which were mild or moderate¹⁷ and comparable to other implantable devices. Ongoing post-approval studies will be imperative to monitor outcomes across a wider variety of UUI patients and pelvic floor surgeons. Of significance, key enhancements were made to the commercial device including the recharge interval increasing from weekly to 1-2 times per year on average, combining the communicator and recharger into a single component, lengthening of battery life from 6 to 15 years and adding the optional pocket dissector tool.

Commercial Experience with the Altaviva™ device

Adding the Altaviva™ device to the UUI toolbox has been well received and allowed for more patient engagement. Early commercial use has been encouraging as expected. Anecdotally, over 80% of my patients are reporting improvement which is aligned with my prior subcutaneous implant results. The procedure has been well-tolerated and safe. The appeal has been high with implanted patients’ ages ranging from less than 40 to over 80 years. The same-day activation simplifies the patient experience. The ability to personalize dosing allows optimization of the therapy for each patient, which could have implications for effectiveness. Patients find the external components intuitive to use. This minimally invasive³ tibial implant has expanded the pool of individuals willing to consider advanced therapy. Just as Bulkamid dramatically increased my treatment rates for SUI with its introduction in 2020 given its ability to improve many with less risk, I anticipate a similar adoption with Altaviva™ as the reimbursement landscape continues to gain traction.

A New Future with the Altaviva™ device

Collectively, the Altaviva™ device is a less intimidating, lower-burden alternative compared to some of the existing advanced therapies. It will expand treatment to patients who might otherwise forgo or discontinue care. Recent survey data demonstrated that willingness to try an advanced therapy increased by 17.6% when a subcutaneous tibial implant is offered¹⁹. Reducing barriers with the Altaviva™ device will enable pelvic floor surgeons to consistently treat more patients.

UUI remains a prevalent and under-treated condition^1,2,4. The diversification of advanced therapy options with Altaviva™ should only improve this bleak space, but continued advocacy for expanded insurance coverage for tibial implants will remain critical to ensure accessibility. The Altaviva™ device represents a huge advancement in peripheral neuromodulation only in its infancy. Its potential to expand usage of advanced therapies with higher patient engagement will continue to evolve. The opportunity to reduce the gap in UUI care has never been so attainable.

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%).

References

1. Stewart W, Rooyen JV, Cundiff G, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-336. doi:10.1007/s00345-002-0301-4
2. US Census Bureau 2020. US adult and under-age-18 populations: 2020 census. https://www.census.gov/library/visualizations/interactive/adult-and-under-the-age-of-18-populations-2020-census.html. Accessed June 20, 2022.
3. 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.
4. Moskowitz D, Adelstein SA, Lucioni A, Lee UJ, Kobashi KC. Use of Third Line Therapy for Overactive Bladder in a Practice with Multiple Subspecialty Providers—Are We Doing Enough? Journal of Urology. 2018;199(3):779-784. doi:10.1016/j.juro.2017.09.102
5. Muller N. What Americans understand and how they are affected by bladder control problems: highlights of recent nationwide consumer research. Urologic nursing. 2005;25(2):109-115. file:///C|/Users/rodinp1/AppData/Local/Quosa/Data/Search417777/NSRes41805820344.pdf
6. Dmochowski RR, Newman DK. Impact of overactive bladder on women in the United States: Results of a national survey. Current Medical Research and Opinion. 2007;23(1):65-76. doi:10.1185/030079907X159533
7. Yeaw J, Benner J, Walt J, Sian S, Smith D. Comparing adherence and persistence across 6 chronic medication classes. Journal of managed care pharmacy : JMCP. 2009;15(9):728-740.
8. Marcelissen T, Rahnama’i M, Snijkers A, Schurch B, Vries PD. Long-term follow-up of intravesical botulinum toxin-A injections in women with idiopathic overactive bladder symptoms. World journal of urology. 2016;(0724-4983). doi:10.1007/s00345-016-1862-y
9. Abreu-Mendes P, Portugal-Rodrigues I, Vale L, et al. Treatment of idiopathic overactive bladder with botulinum toxin: real-life results and patients’ expectations. Porto Biomed J. 2022;7(2):e164. doi:10.1097/j.pbj.0000000000000164
10. Local Coverage Determination for Botulinum Toxin (Botox^TM*) L39857, L39832, L35170, L35172, L39836, L39909, L33274, L38809.
11. Brandon C, Oh C, Brucker BM, et al. Persistence in Percutaneous Tibial Nerve Stimulation Treatment for Overactive Bladder Syndrome is Best Predicted by Patient Global Impression of Improvement Rather Than Symptom-Specific Improvement. Urology. 2021;148(0090-4295):93-99. doi:10.1016/j.urology.2020.12.009
12. Medtronic data on file. NRP1339-56719 Version 2.0
13. Lee. Implantable tibial neuromodulation therapy improves symptoms of urge urinary incontinence from the TITAN 2 pivotal study. J Urol. 2026;215(6):702-712. doi:10.1097/ju.0000000000004958
14. Rogers A, Bragg S, Ferrante K, Thenuwara C, Peterson DKL. Pivotal Study of Leadless Tibial Nerve Stimulation with eCoin® for Urgency Urinary Incontinence: An Open-Label, Single Arm Trial. J Urol. 2021;206(2):399-408. doi:10.1097/JU.0000000000001733
15. eCoin Peripheral Neurostimulator System Patient Manual. Accessed November 28, 2023. https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200036C.pdf
16. Shah A, Aran S. A Review of Magnetic Resonance (MR) Safety: The Essentials to Patient Safety. Cureus. 2023;15(10):e47345. doi:10.7759/cureus.47345
17. Appendix B: Clinical Study Summary. M028929C001 RevC - Clinician Therapy and Programming Guide Altaviva^TM Model P7850N. https://www.medtronic.com/content/dam/emanuals/neuro/M028929C_c_001_view_color.pdf
18. Benson K, Krlin R, Vollstedt A, et al. Safety and Effectiveness of an Implantable Tibial Neuromodulation System For Urgency Urinary Incontinence at 6, 12, and 24‐ Months. In: SUFU 2026 Abstracts Issue of Neurourology and Urodynamics. Vol 45. Neurourology and Urodynamics. 2026:S69-S70. doi:10.1002/nau.70235
19. Kapur A, Harandi AA, Hartman‐Kenzler J, Kim J. Shifts in patient preference of third‐line overactive bladder therapy after introduction of the implantable tibial nerve stimulator. Neurourol Urodyn. 2024;43(4):959-966. doi:10.1002/nau.25421

Important Safety Information

Tibial 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.

Contraindications: Poor 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.

Warnings: This 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 Warnings: Prior 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 Events: In 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