March 25, 2022 – Medtronic announced the first patient implants in the TITAN 2 pivotal study that will evaluate the safety and efficacy of Medtronic’s investigational implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB). The minimally invasive technology stimulates the posterior tibial nerve near the ankle, transmitting electrical impulses that regulate neural activity of the bladder.
Implantable TNM aims to expand access to therapies for incontinence for more physicians and their patients. More than 37 million adults in the U.S. — almost one in six — suffer from OAB.1,2 Of those, 4.5 million are candidates for an advanced therapy, yet only 5% receive treatment.3 Medtronic currently offers percutaneous tibial neuromodulation (PTNM) therapy through its NURO™ system, but PTNM requires patients visit a clinic setting to receive therapy and return for repeat treatments. An implantable TNM device would reduce the burden on patients and physicians by delivering ongoing treatments without the need for additional clinic visits. Additionally, the procedure is less invasive than sacral neuromodulation, the current standard of care.
The TITAN 2 study is a prospective, multicenter, pivotal study to examine the safety and efficacy of the implantable TNM device in people with OAB. The study will include up to 130 patients from up to 30 sites in the U.S. The primary endpoint for the study is six months, and patients will be followed for 24 months.
Launched in April 2021, the TITAN 1 feasibility study characterized the procedure for the implantable TNM device in subjects with bladder incontinence. Upon successful completion of TITAN 2, Medtronic will prepare its submission to the U.S. Food and Drug Administration (FDA) for approval.
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. Recognizing that offering a suite of device options to best fit a patient’s lifestyle and treatment goals would help expand access to advanced therapy, Medtronic further augmented its portfolio with the introduction of the smallest SNM device on the market – the rechargeable InterStim™ Micro – and, most recently, InterStim X™ ― the next generation of its recharge-free SNM device, which provides more than 10 years of battery life without the need to recharge and up to 15 years under low energy settings.