When Sarah Tapani sat in on one of the first Altaviva™ implants, the patient wasn’t focused on the procedure. She was chatting about what she wanted for lunch.
After injecting a local anesthetic, the physician slid an Altaviva™ device — a Medtronic device smaller than a standard stick of gum that treats the symptoms of urinary urge incontinence (the involuntary loss of urine associated with urgency) — into a small incision near the patient’s ankle and closed it with a couple of stitches. The conversation never paused.
Tapani, a senior director and core team lead in the Medtronic tibial portfolio and a driving force behind the engineering that brought the Altaviva™ device to life, took it all in and one thought kept coming to mind: if the patient is planning lunch mid-procedure, we’re doing something right.
The goal of keeping it easy for patients and physicians was so important to the Altaviva™ device team that it became part of the project’s mantra: “hard for us, easy for them.”
The Altaviva™ device was recently named a 2026 Edison Award winner in the Health, Medical and Biotech category. The award honors the most consequential innovations across the globe.
A strategic bet
It’s been known for a long time that stimulating the tibial nerve in the ankle is a way to treat bladder symptoms, according to Medtronic engineers close to this work.
But the team still faced a new, significant challenge. Could they take a therapy that usually requires weekly clinic visits to a small, implantable battery that quietly blended into a patient’s life?
As Medtronic teams approached the challenge, there were three non-negotiables, Tapani said: the device had to be safe, it had to be simple, and it had to get to patients fast.
Those early results mattered. A Medtronic-sponsored clinical trial to assess the safety and effectiveness of Altaviva™ therapy showed implantable tibial neuromodulation delivered relief following 12 months of therapy for people living with urge urinary incontinence1, evidence that the team’s “hard for us, easy for them” approach could translate into lasting patient benefit.
To get Altaviva™ therapy off the ground, the team didn’t have the luxury of working step by step. Engineering, clinical and regulatory strategy, and commercialization all moved in parallel.
“While the pivotal study was getting results, the engineers were squeezing a lot of innovation into that little device,” Tapani said.
The system evolved significantly inside and out, with features like new chipsets, lead elimination, and MRI-compatible design.
One way the teams stuck to their goal of ease-of-use was to resist the urge to add unnecessary features just because they could. Senior Principal Systems Engineer and technical lead on the program Kunal Paralikar called it avoiding “cognitive burden,” or not making patients and clinicians think harder than they need to.
This required attention to detail and thoughtful design touches.
For example, the team incorporated intelligence so the device’s system and the patient’s Altaviva My Therapy application — which is like a phone app, but on a handheld programmer provided by Medtronic — could be synced to update the device’s internal time when the clocks changed for daylight savings’ time — a seemingly simple task that was anything but.
“It was all in an effort to come to an additional therapy option for patients,” he said.
For Tapani, what stands out most isn’t a single technical breakthrough, but the way the team showed up for the people they were building for.
“Patients and clinicians always came first for us,” she said.
That mindset carried the Altaviva™ system from idea to approval to launch — and ultimately, into the lives of patients.
For the team, that’s the measure of success: when years of hard work come together in a therapy designed to fit into patients’ lives.
Learn more about Medtronic.
In addition to risks related to surgery, complications can include pain at the implant site, lower leg pain, infection, and/or technical or device problems. Results vary. Talk to your doctor to see if the Altaviva™ system is right for you.
Important Safety Information
Medtronic Altaviva™ tibial neuromodulation system treats urge urinary incontinence (leakage). It should be used after you have tried other treatments such as medications and behavioral therapy, and they have not worked or you could not tolerate them.
This therapy is not for everyone. The Altaviva™ system is contraindicated (not allowed) for patients who are poor surgical candidates including patients with open wounds, sores, or damaged skin near the treatment area; current or recent history of poor blood circulation in the legs or open sores on the legs from circulation problems; physical changes or previous surgeries where the Altaviva™ device is placed. You must be able to operate or receive assistance in operating the system to be a candidate.
This therapy is not intended for patients who: are not good candidates for surgery or have conditions that make it hard to heal from wounds (such as uncontrolled diabetes, swelling in the lower leg, or nerve problems in the leg); have metal implanted within 5 cm of where the Altaviva™ device would be placed; have a current or unresolved blockage in the urinary tract caused by things like an enlarged prostate, cancer, or urethral narrowing; are allergic to any materials in the Altaviva™ device. The Altaviva™ system may affect or be affected by other implanted medical devices, including pacemakers and defibrillators. Talk to your doctor if you have a pacemaker or other implanted devices. You cannot have diathermy (deep heat treatment using shortwave or microwave electromagnetic energy) if you have an Altaviva™ device. Do not place the charger or ankle band on broken or unhealed skin. Safety and effectiveness have not been established for pregnancy; patients under the age of 18; patients with progressive, systemic neurologic disease; patients with history of urinary retention, or bilateral stimulation.
In addition to risks related to surgery, complications can include pain at the implant site or lower leg pain, infection, wound complications, nerve injury, movement of the implant, undesirable change in bowel or bladder function, uncomfortable or unintended stimulation sensations, unexpected shocking sensation, loss of therapeutic effect, discomfort when recharging, or technical or device problems.
This therapy is not for everyone. This treatment is prescribed by your doctor. Please talk to your doctor to decide whether this therapy is right for you. Your doctor should discuss all potential benefits and risks with you. Although many patients may benefit from the use of this treatment, results may vary.
For complete safety information about this treatment, please visit the Medtronic website at www.medtronic.com.
References
- 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. 0(0). doi:10.1097/JU.0000000000004958
