Medtronic’s TNM Implant Study for Bladder Incontinence Gets FDA Nod

The U.S. Food and Drug Administration (FDA) granted Medtronic approval to proceed with an investigational device exemption (IDE) trial to evaluate its implantable tibial neuromodulation (TNM) device to provide bladder incontinence symptom relief. 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.
 
Almost one in six U.S. adults suffer from overactive bladder (OAB)^1,2. Of those, 4.5 million are candidates for an advanced therapy, but only 5 percent receive treatment³. Implantable TNM aims to expand access to therapies for incontinence.
 
For 25 years, Medtronic has pioneered sacral neuromodulation (SNM) therapy delivered by its implantable primary cell InterStim systems. Later the company enhanced its portfolio with the addition of PTNM delivered through the NURO system. Medtronic further augmented its portfolio with the introduction of a rechargeable SNM device—InterStim Micro.
 
“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,” Brett Wall, executive vice president and president of the Neuroscience Portfolio at Medtronic told the press. “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’s combination of experience with implantable neuromodulation, its existing proprietary technology platforms and its proven effectiveness of PTNM therapy—as shown in the RESET study⁴—uniquely positions the company to develop a new TNM option for the market.
 
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 expected to begin in May.
 
References
¹ Stewart WF, et al. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-336.
² United Nations, Department of Economic and Social Affairs, Population Division (2011). World Population Prospects: The 2010 Revision, CD-ROM Edition.
³ Leede Research, “Views on OAB: A Study for the National Association of Continence.” December 16, 2015.
⁴ Kobashi K, Nitti V, Margolis E et al. A prospective study to evaluate efficacy using the NURO percutaneous neuromodulation system in drug naive patients with overactive bladder syndrome. Urology. 2019;131:77-82.