Sam Brusco, Associate Editor03.25.22
Medtronic achieved the first patient implants in its TITAN2 pivotal study, which is evaluating the firm’s investigational tibial neuromodulation (TNM) device for overactive bladder (OAB).
The minimally invasive technology stimulates the posterior tibial nerve, transmitting electrical impulses that regulate the bladder’s neural activity.
"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," Una Lee, M.D., FPMRS, urology specialist at Virginia Mason Medical Center and national principal investigator for the TITAN 2 study told the press. "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."
Medtronic’s NURO system currently offers percutaneous tibial neuromodulation (PTNM) therapy but patients must visit a clinic to receive therapy and return for repeat treatments. The TNM implant would deliver ongoing therapy without needing additional visits.
The TITAN 2 study will include 130 patients and its primary endpoint is six months. Patients will be followed for 24 months. When TITAN 2 is completed, Medtronic plans to prepare its submission for U.S. Food and Drug Administration (FDA) approval.
"Medtronic's decades of experience with implantable neuromodulation, existing proprietary technology platforms and the proven effectiveness of our PTNM4 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 Medtronic’s Pelvic Health business. "TITAN 2 demonstrates our commitment to investing in the future and expanding access to advanced therapies for the treatment of incontinence."
The minimally invasive technology stimulates the posterior tibial nerve, transmitting electrical impulses that regulate the bladder’s neural activity.
"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," Una Lee, M.D., FPMRS, urology specialist at Virginia Mason Medical Center and national principal investigator for the TITAN 2 study told the press. "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."
Medtronic’s NURO system currently offers percutaneous tibial neuromodulation (PTNM) therapy but patients must visit a clinic to receive therapy and return for repeat treatments. The TNM implant would deliver ongoing therapy without needing additional visits.
The TITAN 2 study will include 130 patients and its primary endpoint is six months. Patients will be followed for 24 months. When TITAN 2 is completed, Medtronic plans to prepare its submission for U.S. Food and Drug Administration (FDA) approval.
"Medtronic's decades of experience with implantable neuromodulation, existing proprietary technology platforms and the proven effectiveness of our PTNM4 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 Medtronic’s Pelvic Health business. "TITAN 2 demonstrates our commitment to investing in the future and expanding access to advanced therapies for the treatment of incontinence."
