Concept: Medtronic has developed implantable tibial neuromodulation (TNM) device that aims to offer a therapy designed to provide relief from symptoms of bladder incontinence. It received US Food and Drug Administration (FDA) approval to conduct an investigational device exemption (IDE) trial, TITAN 1 Feasibility Study for the TNM device.
Nature of Disruption: TITAN 1 Feasibility Study is a multicentre, prospective trial aiming to enroll 20 patients at 8 clinical sites in the United States. The patients will have the device implanted in the posterior tibial nerve near the ankle. This implantable TNM stimulates the posterior tibial nerve, transmitting electrical impulses that regulate the neural activity of the bladder. It delivers treatment by a slim needle that is placed in the ankle where the tibial nerve is located. When the tibial nerve is stimulated, impulses travel to the nerve roots in the spine to block abnormal signals from the bladder and prevent bladder spasms. The study is followed for 12 months to assess the feasibility of the product. Medtronic’s InterStim sacral neuromodulation system is an alteration of nerve activity through targeted delivery of a stimulus, such as electrical stimulation or chemical agents to specific neurological sites in the body. This treats patients with incontinence and the NURO percutaneous tibial neuromodulation (PTNM) as a non-surgical treatment for overactive bladder.
Outlook: Overactive bladder (OAB) is one of the highly prevalent conditions worldwide that affects millions of people worldwide. The adults suffering from OAB are the candidates for advanced therapy, but only a small percent receive treatment. Implantable TNM is considered the future of therapy that aims to expand access to therapies for incontinence. Medtronic addresses this need by developing implantable tibial neuromodulation therapy for bladder incontinence. The FDA-approved study enrollment is anticipated to begin in 2021.