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Altaviva — Implantable Tibial Neuromodulation

Altaviva (Medtronic) is a rechargeable, leadless tibial neurostimulator. FDA approved it on September 18, 2025 for urgency urinary incontinence after an inadequate response to, or intolerance of, more conservative treatment.[1]

Hardware and Implantation​

The implant incorporates its electrodes, electronics and rechargeable battery. It is placed in a lower-leg pocket on the deep fascia, above the medial malleolus and anterior to the Achilles tendon. The implant manual specifically warns against dissecting through the deep fascia. Local-anesthetic placement is possible; the necessary anesthesia and setting depend on the patient and procedure.[2]

Therapy can be activated shortly after implantation. The system still needs external equipment: a patient handset and wireless recharger and communicator. It does not require wearing an external power unit during each stimulation session. Recharge frequency depends on programming and placement; the manufacturer's typical once- or twice-yearly schedule and projected 15-year device life are conditional specifications.[3][2]

TITAN 2 — What Approval Evidence Shows​

TITAN 2 was prospective, multicenter and single arm, not randomized. Of 188 enrolled people, 126 received an implant; 95% of implanted participants were women.[1] Among TITAN 2 participants who had failed or could not tolerate at least two OAB medications, approximately 59% had at least a 50% reduction in daily UUI episodes at six months (complete-case analysis) and 61% at 12 months (post hoc imputed analysis of all 126 implanted participants).[1][3]

Through 12 months after implantation, FDA’s safety review reported 30 device- or procedure-related events in 25/126 participants. In addition to the reported serious C. difficile colitis event, FDA considered a wound infection requiring explantation serious. In TITAN 2, three devices were explanted before the 12-month visit, and FDA reported eight further explants for lack of efficacy after 12-month follow-up; infection, wound problems, pain and revision remain counseling topics.[1]

Selection and Safety​

FDA labeling contraindicates implantation in poor surgical candidates with skin lesions or compromised skin integrity, current or recent lower-leg venous insufficiency or stasis ulcers, or implant-site anatomy or previous surgery that precludes device use, and in patients unable to operate the system or receive assistance.[1] The manufacturer's US safety summary says not to implant the neurostimulator within 5 cm of another metal implant, because recharging within that distance may cause heating and tissue damage. It says not to place the recharger or ankle band in direct contact with an unhealed wound; continuous stimulation and shortwave or microwave diathermy should not be used.[2] Medtronic states that Altaviva is not intended for patients with current or unresolved mechanical obstruction, including urethral stricture; known allergy to implant materials; or poor wound-healing risk, including severe uncontrolled diabetes, clinically significant lower-leg edema or clinically significant peripheral neuropathy.[2] Follow the complete model-specific instructions for cardiac devices, other procedures and postoperative activity. MR Conditional does not mean unrestricted MRI: confirm the implant and the specified 1.5T/3T scanning conditions.[2]

Choosing Among Tibial Devices​

Compare the daily work each system requires: eCoin provides programmed intermittent stimulation from a primary battery; Revi requires an external wearable during treatment; Altaviva requires periodic implant recharging.

The 2024 AUA/SUFU OAB guideline (Statement 25) recommends that clinicians offer sacral neuromodulation, tibial nerve stimulation and/or intradetrusor botulinum toxin after inadequate response to, or intolerable effects from, pharmacotherapy or behavioral therapy .[4] The 2024 guideline gave no recommendation specific to implantable tibial systems because direct comparisons with other OAB treatments or placebo were lacking at that time.[4] In a planned secondary analysis of a randomized, sham-controlled trial of the Intibia system in patients with UUI, 86/137 assigned active stimulation (62.8%) and 28/67 assigned sham (41.8%) exceeded the clinically important OABq-SF symptom-bother improvement threshold at three months; sham recipients crossed over afterward.[5]

See also: PTNS systems, InterStim.

References​

1. FDA. Altaviva Implantable Tibial Neuromodulation System: Summary of Safety and Effectiveness Data. P240011, approved September 18, 2025. SSED.

2. Medtronic. Altaviva labeling and important safety information. Implant manual M028930C001 Rev C, September 16, 2025; current US safety information. FDA-posted manuals; manufacturer safety and specifications.

3. Lee U, Xavier K, Carey J, et al. Implantable Tibial Neuromodulation Therapy Improves Symptoms of Urge Urinary Incontinence From the TITAN 2 Pivotal Study. J Urol. 2026;215:702–712. doi:10.1097/JU.0000000000004958.

4. AUA/SUFU. Idiopathic Overactive Bladder Guideline, 2024. Statement 25 and the implantable tibial nerve stimulation discussion. Unabridged guideline.

5. Mangel J, Miller K, Erickson T, Dieter A, Roovers JP, Matthews CA. "Randomized, Sham-Controlled, Double-Blind Trial of the Intibia System in Urge Urinary Incontinence: Quality-of-Life Outcomes." Int Urogynecol J. 2026. doi:10.1007/s00192-026-06636-1