The study will recruit 20 patients at eight sites in the US
Medtronic has secured approval from the US Food and Drug Administration (FDA) to launch a clinical study of its implantable tibial neuromodulation (TNM) device for bladder incontinence.
The TITAN 1 feasibility study will assess the efficacy of an implantable TNM device in offering relief from symptoms of bladder incontinence.
The prospective, multicentre and feasibility study will be conducted to characterise the procedure for the implantable TNM device in subjects with bladder incontinence.
According to the company, implantable TNM intends to expand access to therapies for patients with incontinence .
Implantable TNM is said to stimulate the posterior tibial nerve near the ankle, thereby helping to transmit electrical impulses that regulate the neural activity of the bladder.
With enrollment beginning next month, the study will recruit 20 patients at eight sites in the US. The patients will be followed for one year.
Medtronic neuroscience portfolio president and executive vice president Brett Wall said: “We remain completely committed to our sacral neuromodulation portfolio because this option is, and will continue to be, the best choice for many patients.
“Implantable TNM aims to be an extension of our belief that choice matters. No two patients are the same and their therapy should not be either.”
Medtronic offers sacral neuromodulation (SNM) products such as implantable primary cell InterStim systems, NURO system for PTNM and InterStim Micro rechargeable SNM device.
Last month, the company secured FDA approval for its Harmony transcatheter pulmonary valve (TPV) system to treat patients with congenital heart disease.
Harmony TPV is a non-surgical heart valve to treat paediatric and adult patients with a native or surgically-repaired right ventricular outflow tract (RVOT), the part of the heart that takes blood out of the right ventricle to the lungs.