April 27, 2021 – Medtronic plc (Dublin, Ireland) received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate its internally developed implantable tibial neuromodulation (TNM) device — a therapy designed to provide relief from symptoms of bladder incontinence.
The TITAN 1 Feasibility Study is a prospective, multicenter, feasibility study to characterize the procedure for the implantable TNM device in subjects with bladder incontinence.
Implantable TNM aims to expand access to therapies for incontinence for more physicians and their patients.
Implantable TNM stimulates the posterior tibial nerve near the ankle, transmitting electrical impulses that regulate neural activity of the bladder. Twenty patients from eight sites in the U.S. will receive a device and will be followed for 12 months. Enrollment is anticipated to begin in May 2021.