Medtronic has announced that its investigational implantable tibial neuromodulation (TNM) device has been implanted in the first patient for its TITAN 2 pivotal study.
The multicentre, prospective study is designed to assess the TNM device’s safety and efficacy in people with overactive bladder (OAB).
It will include approximately 130 OAB patients, recruited from up to 30 sites across the US.
At present, the company provides percutaneous tibial neuromodulation (PTNM) therapy through its Nuro system, however, the therapy needs repeated patient visits to a clinic to receive the therapy.
The minimally invasive TNM device works by stimulating the posterior tibial nerve near the ankle to transmit electrical impulses that regulate the bladder’s neural activity.
Medtronic noted that the device would deliver ongoing treatment without requiring additional clinic visits.
This helps to reduce the burden on both patients and physicians.
Medtronic pelvic health business president Mira Sahney said: “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.
“TITAN 2 demonstrates our commitment to investing in the future and expanding access to advanced therapies for the treatment of incontinence.”
The company launched the TITAN 1 feasibility study last April to characterise the procedure for the implantable TNM device in bladder incontinence patients.
It will prepare to file regulatory submission to seek approval from the US Food and Drug Administration (FDA) after completion of the TITAN 2 study.
This month, Rockley Photonics and Medtronic agreed to a partnership for the development of the next generation of wearable healthcare monitoring devices.