The Fridley, Minn.-based company said the device is designed to deliver percutaneous tibial neuromodulation treatment, a minimally invasive office-based procedure which provides a “measurable reduction” in urinary frequency or urinary incontinence.
“Many people with OAB are unsatisfied with current treatments and a significant number are not seeking treatment altogether. With the Nuro System, I can offer patients another option to restore bladder function and improve quality of life without the side effects of medication. This minimally invasive therapy targets the brain-bladder miscommunication and can help improve quality of life in a meaningful way,” Dr. Harriette Scarpero of Nashville, Tenn.’s Associated Urologists said in a press release.
The company’s Nuro system is designed to deliver electrical pulses to the tibial nerve via a needle placed in the skin near the ankle attached to a neurostimulator. The therapy is provided over 30 minute sessions weekly for 12 weeks and can extend further depending on physician prescription.
The most common side effect of treatments with the device are mild pain or skin inflammation at or near the stimulation site, Medtronic said.
“So many suffer from OAB and the majority are either not treated or not finding relief with other treatments, so Medtronic is pleased to offer another option along the care pathway. Our hope is that our expanding neuromodulation portfolio can help a broader range of patients get their lives back,” gastro/urology therapies prez & GM Linnea Burman said in a prepared statement.
Medtronic said that PTNM demonstrated significantly decresed numbers of incontinence episodes and voids per day, reduced number of urgency and urge incontinence episodes and increased voiding volume in clinical trials.