Medtronic (NYSE:MDT) announced that it completed the first patient implants in the Titan 2 pivotal study of its investigational neuromodulation device.
Fridley, Minnesota-based Medtronic’s Titan 2 trial will evaluate the safety and efficacy of the company’s implantable tibial neuromodulation (TNM) device in people with overactive bladder (OAB).
The company designed the minimally invasive implantable TNM to stimulate the posterior tibial nerve near the ankle, transmitting electrical impulses that regulate the neural activity of the bladder. Medtronic said an implantable TNM device could reduce the burden on patients and physicians by delivering ongoing treatments without the need for additional clinical visits, while the procedure is less invasive than sacral neuromodulation, which is the current standard of care.
Titan 2 is a prospective, multicenter, pivotal study that will include up to 130 patients from up to 30 sites in the U.S. with a primary endpoint of six months. Patients will be followed for 24 months. The company’s Titan 1 feasibility study characterized the procedure for the implantable TNM device in subjects with bladder incontinence.
Medtronic said it will prepare its submission for FDA approval of the implantable TNM system upon the successful completion of Titan 2.
“Medtronic’s decades of experience with implantable neuromodulation, existing proprietary technology platforms and the proven effectiveness of our [percutaneous tibial neuromodulation] 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,” Mira Sahney, president of Medtronic’s Pelvic Health business, said in a news release. “Titan 2 demonstrates our commitment to investing in the future and expanding access to advanced therapies for the treatment of incontinence.”