Medtronic Launches Altaviva, the First Implantable Tibial Nerve Stimulator for Urge Urinary Incontinence

Medtronic Announces Its Tibial Nerve Stimulator---AltavivaApproved by the FDA for marketing,AltavivaSpecifically designed for the treatment of urge incontinence.

PI Evaluation

"Altaviva Brings Significant Advancements for Patients with Urgency Urinary Incontinence, Who Often Must Weigh Treatment Options Based on Invasiveness and Potential Side Effects. The Introduction of This Simple Treatment is Exciting, and It is Believed That Altaviva Has the Potential to Transform Patients' Lives and Bring New Hope to More People."

---Kevin Benson  Sanford Health 

Executive Evaluation

"Launching Altaviva is our honor. Society has long instilled the misconception that people will inevitably lose bladder control. We say 'enough'! Common occurrences do not equate to normalcy. Altaviva aims to support patients' daily lives with the power of technology, offering a simple and effective treatment experience, opening the door to renewed hope and improved quality of life."

---Emily Elswick President of Pelvic Health Business, Neurosciences Division, Medtronic

"Too many people silently struggle with urgency and loss of control, often mistakenly believing that pads are the only option. The Altaviva device represents a transformative milestone, ushering in a new era of bladder control treatment with advanced features. Medtronic has solidified its global leadership in neuromodulation through continuous innovation, and this FDA approval once again demonstrates our commitment to 'truly changing lives with therapy.'"

---Brett Wall  Executive Vice President and President of Medtronic Neuroscience Business

According to statistics, there are approximately 43 Million (or one in every six) adults have bladder control problems. Among them, nearly 16 million suffer from urge incontinence — a common symptom of overactive bladder (OAB), characterized by sudden, intense urges to urinate, often followed by involuntary leakage before reaching the toilet. However, only one-quarter of those with bladder control issues have ever discussed their symptoms with a doctor. This condition can impact quality of life, mental health, and sleep, while also imposing significant economic burdens on both society and patients.

Urinary incontinence is a huge market, and Medtronic has always been the main participant in this field. Its development ofSacral Nerve StimulatorThe InterStim series is one of the best choices for treating urinary incontinence. In order to maintain its dominant position in this market, Medtronic once went to war with Boston Scientific (Axonics), but the two eventually reached a settlement earlier this year. One reason for reaching the settlement was that Medtronic...Unable to win in intellectual property litigation, on the other hand, the rise of new technologies (Tibial Nerve Stimulator) The significance of allowing both parties to continue the major battle has become less meaningful.

CurrentlyThe penetration rate of sacral nerve stimulators in the U.S. market is very low.OAB Patients ReceiveSacral Nerve Stimulator Treatment. CausesSacral Nerve StimulatorLow Penetration Rate Reasons, Sacral Nerve StimulatorThe incidence of related adverse reactions and the proportion of repeat surgical interventions are high.In additionSacral Nerve Stimulator TreatmentTheComplexity, invasiveness, complexity andCostEtc.,Lead toFew patients are willing to accept.

WithThe tibial nerve stimulator appears,The future prospect of sacral nerve stimulators has become relatively dim. Currently, the FDA has approved multiple products.Sacral Nerve Stimulator, for exampleValencia TechnologieseCoin, BlueWind Medical'sRENOVA、Neuspera Medical'sNeuspera. The rise of these innovative companies truly impacted Medtronic's leadership position in the urinary incontinence field, which led Medtronic to initiate changes in 2022.AltavivaClinical research, and it was finally approved by the FDA for marketing this year. But it is still 3 years later than these enterprises, but fortunately earlier than Boston Scientific. After all, Boston Scientific hasn't started its own...Sacral Nerve Stimulator Clinical Trial. This gives Medtronic the opportunity to evaluate its strong sales network and regain lost market share.

AndWithAltavivaListed, Medtronic becomes the only one owningUrge IncontinenceA company specializing in a full range of neuromodulation therapies.

Altaviva

Altavivais an implantableTibial Nerve Stimulator, specifically designed for the treatment of urgency urinary incontinence.AltavivaPatients with the implant can return home after treatment activation, a first in the field of implantable tibial nerve therapy.

AltavivaAllowImplanted in the ankle through minimally invasive surgery without the need for sedatives or image guidance., with a length of about half that of a stick of gum, is located between the subcutaneous layer and the upper fascia. It helps restore signal transmission between the brain and the bladder by sending electrical pulses to the tibial nerve, thereby regulating bladder control function.

AltavivaWith a 15-year battery life under expected treatment settings, it can automatically deliver therapy without requiring daily patient intervention or manual adjustments. Each charge takes only 30 minutes at the default charging speed, eliminating the need for daily use of a home charging device. To meet practical needs, the device is MRI-compatible, allowing patients to confidently undergo both scheduled and unexpected imaging examinations.