Medtronic the global leader in healthcare technology, today announced 12-month data from the TITAN 2 pivotal clinical trial are now available online in The Journal of Urology demonstrates that the Medtronic Altaviva™ implantable tibial neuromodulation (ITNM) device delivers significant and sustained symptoms at 12 months, while maintaining a favorable safety profile.

The TITAN 2 pivotal study imposed the strictest requirements for prior drug failure and drug discontinuation among Implantable Tibial Neuromodulation clinical trials and included patients with various BMI and comorbidities.

Key Results from TITAN 2
All primary and secondary endpoints in this study were met, with sustained improvement through 12 months. Notably:

• Patients with 100% UUI Reduction: Approximately 20 percent of patients had no UUI episodes at all at 12 months.
• Patient-Reported Outcomes: 80 percent of patients reported their condition improved according to the Patient Global Impression of Improvement (PGI-I).
• Sustained Efficacy: At 12 months, 61 percent of study participants maintained ≥ 50 percent reduction in daily UUI episodes.
• Improved Urinary Symptoms: Statistically significant improvements were observed in UUI episodes, with benefits maintained through one year.

Advancing Treatment Options for Overactive Bladder Symptoms
UUI, a common symptom of overactive bladder, can significantly impair quality of life. Altaviva™ system targets the tibial nerve to modulate neural pathways associated with bladder control, offering a minimally invasive, simple option for patients.

“The TITAN 2 12-month data show that the Altaviva implantable tibial neuromodulation device can provide meaningful, durable symptom improvement for patients with urge urinary incontinence who have not responded to traditional therapies,” said Dr. Keith Xavier, MD, URPS, of Urology Partners in North Texas. “Notably, these outcomes were achieved without the use of concurrent medications, and almost 30 percent of the study participants had tried previous advanced overactive bladder options, highlighting the potential for sustained symptom relief among the real-world patient population.”

These data add to the expanding body of evidence indicating that the Altaviva device is a safe, effective and simple option for treating UUI. Medtronic plans to present 24-month TITAN 2 data at the 2026 Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Conference on February 28^th.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn.

Contact
Laurel Hood
Public Relations
763-514-0249

Ingrid Goldberg
Investor Relations
+1-763-505-2696