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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. It is not an established default replacement for sacral neuromodulation.[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, but early activation does not establish immediate symptom improvement. The system still needs external equipment: a patient handset and wireless recharger/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. The published report found approximately 59% responders at six months and 61% at 12 months, defining response as at least a 50% reduction in daily UUI episodes. These figures include the study's missing-data methods and do not show superiority to another treatment.[3]

FDA's safety review reported 30 device/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. Infection, wound problems, pain, loss of benefit and revision/explantation remain relevant counseling topics. Longer follow-up is needed; a projected battery life is not observed long-term clinical durability.[1]

Selection and Safety​

Assess lower-leg skin, vascular health, prior surgery and the patient's ability to operate the system or receive assistance. The US safety summary warns against implantation near other metal implants, charging before wound healing, continuous stimulation and shortwave/microwave diathermy. 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. Their trials differ in populations, denominators and follow-up, so comparing headline response percentages cannot rank effectiveness.

The 2024 AUA/SUFU guideline supports individualized OAB treatment, but its specific Grade A recommendation names percutaneous tibial stimulation. Its implantable-device discussion did not issue a device-specific recommendation because comparative evidence was lacking.[4]

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. Statements 23–25 and implantable-tibial-stimulation discussion, pp 30–32. Unabridged guideline.