#United States #FDA Approval #Medtronic #Galway #Altaviva

Medtronic Introduces the Altaviva™ Device for Urge Urinary Incontinence

Medtronic plc, a recognized leader in healthcare technology, proudly announces that it has achieved U.S. Food and Drug Administration (FDA) approval for its innovative product, the Altaviva™ device. This advanced solution is a minimally invasive implantable tibial neuromodulation (ITNM) therapy, designed specifically to aid individuals suffering from urge urinary incontinence.

The Need for New Solutions

Urinary bladder control issues are alarmingly prevalent, impacting around 43 million adults in the United States, which translates to approximately one in six individuals. Out of these, nearly 16 million people contend with urge urinary incontinence, characterized by sudden and intense urges to urinate and involuntary leaks. Shockingly, only about 25% of these individuals have had discussions about their bladder control issues with healthcare providers. The implications of this common problem extend far beyond physical discomfort; they can severely affect one’s quality of life, mental well-being, and sleep, while also imposing heavy economic burdens both on patients and the healthcare system.

A Breakthrough in Treatment

Dr. Kevin Benson, a Urogynecologist at Sanford Health and one of the investigators for the pivotal Altaviva device study (TITAN 2), expressed enthusiasm about this latest development, stating, "The Altaviva device represents a significant advancement... I'm excited to offer my patients this simple experience." This innovation allows patients to return home immediately after the device is activated post-implantation, marking a first for implantable tibial devices aimed at treating urge urinary incontinence.

During a straightforward, minimally invasive procedure that does not require sedation or advanced imaging techniques, the Altaviva device is positioned near the ankle. This device, about the size of half a stick of chewing gum, is implanted just beneath the skin. It operates by sending electrical signals to the tibial nerve, helping restore lost communication pathways between the bladder and the brain to significantly improve bladder regulation.

Emily Elswick, president of the Pelvic Health business within Medtronic’s Neuroscience Portfolio, commented, "For too long, society has told people it is normal to lose bladder control. We say enough! What is common does not mean it is normal." The introduction of the Altaviva device strives to offer patients a straightforward and effective way to manage urge urinary incontinence, thus reinstating hope and enhancing their quality of life.

Designed with Patients’ Needs in Mind

The Altaviva device boasts a remarkable 15-year battery life, functioning automatically under expected therapy conditions. It eliminates the need for daily interference from patients; recharging takes merely 30 minutes at the designated recharging speed. In a remarkable display of foresight, the device is also MRI-compatible, ensuring that patients undergo necessary imaging without concerns around their implant.

"Too many people silently tolerate urgency and loss of bladder control, feeling that incontinence pads or diapers are their only options," remarked Brett Wall, executive vice president of the Medtronic Neuroscience Portfolio. "The Altaviva device is a transformative milestone in bladder control therapy that incorporates advanced features. Through tireless innovation, Medtronic has firmly established itself as a leader in the realm of neuromodulation, and this FDA approval reinforces our commitment to delivering life-changing therapies."

With a rich history spanning over three decades, Medtronic's neuromodulation devices have consistently improved the lives of individuals facing bladder control challenges. The launch of the Altaviva device positions Medtronic as the sole provider with a complete portfolio of neuromodulation therapies for this condition.

For those interested in further understanding the Altaviva device and its implications for treating urge urinary incontinence, Medtronic will host an investor call on October 9, 2025, at 10 am CST. During this session, Emily Elswick will delve deeper into the project and its anticipated impact. A live webcast will be accessible on Medtronic's Investor Relations website.

About Medtronic

Medtronic plc, with its headquarters in Galway, Ireland, is a premier global healthcare technology company dedicated to tackling some of the most pressing health challenges. With a mission to alleviate pain, restore health, and extend life, Medtronic employs a team of over 95,000 dedicated professionals across more than 150 countries. Their diverse technologies address around 70 health conditions, ensuring the company remains at the forefront of medical innovation. To learn more about Medtronic, visit www.Medtronic.com.

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This article contains forward-looking statements that involve risks and uncertainties. Actual results may differ significantly from projected outcomes, which are detailed in Medtronic's reports to the Securities and Exchange Commission.