Medtronic has announced approval from the US Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate its internally-developed, implantable tibial neuromodulation (TNM) device, which is designed to provide relief from symptoms of bladder incontinence.
According to the company, the TITAN 1 Feasibility Study is a prospective, multicentre study to characterise the procedure for its implantable TNM device, which stimulates the posterior tibial nerve near the ankle, transmitting electrical impulses that regulate neural activity of the bladder, in order to treat patients with incontinence.
Some 20 patients from eight sites in the USA will receive a device and will then be followed for 12 months. Enrolment in the trial is anticipated to begin in May 2021.
“Our goal is to stay at the forefront of therapy innovation, and we believe implantable TNM is an important part of the future of therapy for bladder incontinence,” said Brett Wall, executive vice president and president of the Neuroscience Portfolio at Medtronic. “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.”
In a press release, Medtronic stated that more than 37 million adults in the USA—almost one in six—suffer from overactive bladder (OAB). Of those, 4.5 million (12.2%) are candidates for an advanced therapy, yet only 5% receive treatment.
Implantable TNM therefore aims to expand access to incontinence therapies for more physicians and their patients. For 25 years, Medtronic has pioneered sacral neuromodulation (SNM) therapy, delivered via its implantable primary cell InterStim systems, later extending its portfolio with the addition of percutaneous tibial neuromodulation (PTNM) through the NURO system. Medtronic also claims to be the only company to offer a suite of neuromodulation options for the treatment of incontinence.
Medtronic’s combination of experience with implantable neuromodulation, in addition to its existing proprietary technology platforms and its proven effectiveness of PTNM therapy—as shown in the RESET study—uniquely positions the company to develop a new TNM option for the market, it stated.