Medtronic plc says the first patient implants in the TITAN 2 pivotal study will evaluate the safety and efficacy of its investigational implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB).
Background
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. suffer from OAB. Of those, 4.5 million are candidates for an advanced therapy, yet only 5% receive treatment. 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.
Investigator comments
“Implantable TNM has the potential to offer relief to millions who suffer from bladder incontinence through a new approach that will provide greater convenience and more options for physicians and patients,” said Una Lee, M.D., FPMRS, urology specialist at Virginia Mason Medical Center and national principal investigator for the TITAN 2 study. “The first patient implants in the Titan 2 study marks the beginning of what may be an important part of the future for better bladder control.”
OAB study
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. FDA for approval.
Company comments
“Medtronic’s decades of experience with implantable neuromodulation, existing proprietary technology platforms and the proven effectiveness of our PTNM therapy uniquely positions us to bring implantable TNM to the market. We’re confident this new option will truly meet the needs of physicians and patients,” said Mira Sahney, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic.
“TITAN 2 demonstrates our commitment to investing in the future and expanding access to advanced therapies for the treatment of 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. 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.
published: March 25, 2022 in: Clinical Studies/Trials, Medtronic, Urology