USA – Medtronic has finished the first patient’s implantation of its experimental tibial neuromodulation (TNM) device to treat urinary incontinence.

The implantation is part of the TITAN 2 study, which is evaluating the TNM device’s safety and efficacy in people with overactive bladder (OAB).

OAB is a condition that occurs when the urinary bladder is unable to hold urine normally. Urinary incontinence occurs when people with OAB lose control of their bladder.

Medtronic currently provides percutaneous tibial neuromodulation (PTNM) therapy through its NURO system, which requires patients to return to a clinical setting for treatment on multiple occasions.

According to the company, an implantable TNM device would provide ongoing treatments without the need for additional clinic visits, reducing the burden on patients and physicians.

The minimally invasive device works by stimulating the posterior tibial nerve near the ankle, causing electrical impulses to be transmitted that regulate bladder neural activity.

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, multicenter 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.

The company launched the TITAN 1 feasibility study in April of last year to characterize the procedure for the implantable TNM device in bladder incontinence patients.

Following the completion of the TITAN 2 study, Medtronic plans to file a regulatory submission with the US Food and Drug Administration (FDA) to seek 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 market,” said Mira Sahney, president of Medtronic’s pelvic health business.

“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 Sacral neuromodulation (SNM) therapy for 25 years, initially through its implantable primary cell InterStim systems, enhancing it with addition of percutaneous tibial neuromodulation therapy.

The US Food and Drug Administration (FDA) approved the company’s InterStim X system for bladder and bowel control last month.

The system makes use of proprietary battery chemistry to provide more than ten years of battery life without the need for recharging.

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