The new Altaviva™ device is implanted near the ankle, designed to regulate bladder control by restoring communication between the bladder and the brain.

Central Ohio Urology announced that Dr. Jeffrey Carey and Dr. Linda Osborne have implanted the first Altaviva™ devices, a new treatment option to manage bladder control symptoms, in an Ambulatory Surgery Center in Central Ohio.

The device, which is implanted near the ankle above the tibial nerve, is approved by the U.S. Food and Drug Administration (FDA) to treat urge urinary incontinence (UUI).

Over 16 million adults in the United States experience UUI,[1,2] a symptom of overactive bladder (OAB) that is characterized by a sudden, intense urge to urinate, often followed by involuntary leaks before reaching the bathroom.

[3]The Altaviva device, developed by Medtronic, offers a minimally invasive[4] treatment option with several key benefits:
• No sedation or radiation is required for the procedure[5]
• Same-day therapy activation[6]
• MRI compatibility from day one[7]
• The device battery lasts up to15 years*,[6]

The inaugural procedure was performed by Dr. Jeffrey Carey who stated, “It’s exciting to offer the Altaviva device to my patients with urge urinary incontinence. This is an additional option for patients who have struggled to find relief, is expanding access to urge urinary incontinence treatments, and I look forward to seeing how this therapy can help patients.”

The leadless Altaviva™ device is approximately half the length of a stick of chewing gum. It is implanted near the ankle and sends electrical pulses to the tibial nerve to help restore the communication pathway between the bladder and brain.[8,9] Recharging is needed once or twice a year under standard settings and will take up to 30 minutes for the device to go from zero to 100% charged, 10 eliminating the need for daily at-home charging equipment. This treatment, called tibial neuromodulation, is a proven therapy for reducing bladder control symptoms.[11-16]

Central Ohio Urology Group is committed to providing cutting-edge treatments to its patients. If you or someone you know is experiencing bladder control symptoms, visit www.centralohiourology.com/altaviva to learn if you are a candidate for the Altaviva device.

References:
* Based on clinical and bench testing for expected therapy settings

1. Stewart WF, Van Rooyen JB, Cundiff GW, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003;20(6):327-336.
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 January 31, 2025.
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. 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.
5. M028930C001 RevC – Altaviva™ Model P7850N Neurostimulator Implant Manual.
6. M028929C001 RevC – Clinician Therapy and Programming Guide Altaviva™ Model P7850N.
7. M028949C001 RevC – MRI Guidelines for Altaviva™ Neurostimulator.
8. 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.
9. 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.
10. NDHF1604-222910 T-Entry System – Recharge Performance Design Verification Test Report
11. 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.
12. 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.
13. 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.
14. 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.
15. 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.
16. Appendix B: Clinical Study Summary. M028929C001 RevC – Clinician Therapy and Programming Guide Altaviva™ Model P7850N.