Medtronic has revealed 12-month data from the TITAN 2 pivotal trial showing that its Altaviva implantable tibial neuromodulation (ITNM) device provides significant, sustained symptoms at 12 months with a favorable safety profile.

Altaviva targets the tibial nerve to modulate neural pathways related to bladder control. Cleared by the U.S. Food and Drug Administration (FDA) in September, it offers a minimally invasive, simple option for patients suffering from urinary urge incontinence (UUI).

The company said the study imposed the strictest requirements for drug failure and discontinuation among INTM clinical trials. It included patients with various BMI and comorbidities.

All primary and secondary endpoints were met, with sustained improvement through 12 months. About 20% of patients had no UUI episodes at all at 12 months, and 80% reported their condition improved. 61% of participants kept ≥50% reduction in daily UUI episodes.

“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.”

Medtronic expects to present 24-month TITAN 2 data at this year’s Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction Conference.