Medtronic has completed the implantation of first patient with its experimental tibial neuromodulation (TNM) device to treat urinary incontinence.
The implantation is part of the TITAN 2 study, which evaluates safety and efficacy of the TNM device in people with overactive bladder (OAB).
OAB is a condition where the urinary bladder fails to hold urine normally. People with OAB lose control of their bladder, which is known as urinary incontinence.
Medtronic currently offers percutaneous tibial neuromodulation (PTNM) therapy through its NURO system, which requires repeated patient visits to a clinical setting to receive therapy.
Implantable TNM device would deliver ongoing treatments without requiring additional clinic visits, and reduce the burden on patients and physicians, said the company.
The minimally invasive device works by stimulating the posterior tibial nerve near the ankle, to transmit electrical impulses that regulate neural activity of the bladder.
TITAN 2 study principal investigator Una Lee said: “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.
“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.”
The TITAN 2 study is a prospective, multicentre study designed to assess the implantable TNM device in nearly 130 OAB patients at up to 30 sites across the US.
The primary endpoint for the study is six months, and patients will be followed for 24 months.
In April last year, the company has launched TITAN 1 feasibility study to characterise the procedure for the implantable TNM device in bladder incontinence patients.
Upon completion of TITAN 2 study, Medtronic is anticipated to file regulatory submission with the US Food and Drug Administration (FDA), seeking approval.
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.
“We’re confident this new option will truly meet the needs of physicians and patients. TITAN 2 demonstrates our commitment to investing in the future and expanding access to advanced therapies for the treatment of incontinence.”
Medtronic has been offering SNM therapy for 25 years, initially through its implantable primary cell InterStim systems, enhancing it with addition of PTNM therapy.
Last month, the US Food and Drug Administration (FDA) has approved the company’s InterStim X system for bladder and bowel control.
The system leverages unique battery chemistry that facilitates more than 10 years of battery life, without needing to recharge.
