(RTTNews) - Medtronic plc (MDT) announced FDA approval to proceed with an investigational device exemption trial to evaluate its implantable tibial neuromodulation 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 tibial neuromodulation device in subjects with bladder incontinence. Medtronic said 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.
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