Altaviva™ — Medtronic Implantable Tibial Nerve Stimulator

The Altaviva™ (Medtronic) is the newest FDA-approved implantable tibial nerve stimulator — cleared in September 2025 for refractory urge urinary incontinence. Medtronic's entry into the ITNS space puts all three dominant neuromodulation manufacturers (Medtronic InterStim, Axonics, now Medtronic Altaviva) in the same device category — a signal of ITNS as the emerging default alternative to SNM for non-neurogenic OAB.

Design

~Half the length of a stick of chewing gum — small profile designed for easy placement
Subcutaneous implant placed above the fascia, near the ankle
Single-unit self-contained device — lead, battery, and electronics integrated
Delivers electrical impulses to the tibial nerve to restore bladder–brain communication
Therapy activated at the time of implantation — a first among implantable tibial devices; patients return home with stimulation already running

Implantation

Minimally invasive office procedure — no sedation required, no imaging guidance required
Local anesthetic only
Small incision near the ankle
Device positioned subcutaneously
Patient ambulatory immediately

Clinical Evidence

Approval based on the TITAN 2 pivotal trial — 188 adult patients across 29 US sites, randomized-controlled design:

Primary endpoint: ≥50% reduction in urge urinary incontinence episodes at 6 months post-implant
Safety profile: 5 device/procedure/therapy-related adverse events in 3 patients; 1 serious adverse event (wound infection requiring explant at 6 weeks)

Advantages

No sedation or imaging for placement — simplest implant workflow in the ITNS class
Therapy active at home — no delay between implantation and benefit
Medtronic ecosystem — integrates with the company's existing SNM, spinal-cord-stimulation, and device-programming infrastructure familiar to neurology and urology users
Self-contained — no wearable required (contrast with Revi)

Limitations

Newest to market (September 2025) — long-term real-world outcome data still accumulating
Battery life and device lifespan data still maturing as the device enters widespread clinical use
Single-indication approval — UUI only

Positioning in the ITNS Landscape

Feature	eCoin	Revi	Altaviva
FDA approval	Mar 2022	Aug 2023	Sep 2025
Form factor	Nickel-sized self-contained	Implant + wearable external	Gum-stick self-contained
Power	Internal battery	External wireless	Internal battery
Placement	Office, LA	Office, LA	Office, LA, no sedation/imaging
Therapy onset	After healing period	Patient-activated sessions	Active at home from day 1
Manufacturer	Valencia → Boston Scientific	BlueWind Medical	Medtronic

Design​

Implantation​

Clinical Evidence​

Advantages​

Limitations​

Positioning in the ITNS Landscape​