The FDA has approved an investigational device exemption (IDE) trial for a novel therapy to alleviate bladder incontinence, Medtronic has announced. The company will conduct a multicenter prospective feasibility study of an implantable device that uses an electrical impulse to treat overactive bladder.
The novel device from Medtronic, which is based on pre-existing technology, uses an electrical signal to stimulate the posterior tibial nerve, located near the ankle. These electrical impulses “regulate neural activity of the bladder,” according to a press release.
Only about 5% of 4.5 million patients in the U.S. who qualify for advanced therapy for overactive bladder receive treatment, Medtronic said in its announcement.
In the TITAN 1 Feasibility Study, researchers will implant devices in 20 American patients with bladder incontinence at eight sites in the United States. Enrollment for the trial began in May, and patients will be followed for 1 year.
"Our goal is to stay at the forefront of therapy innovation, and we believe implantable tibial neuromodulation is an important part of the future of therapy for bladder incontinence," Brett Wall, executive vice president and president of the Neuroscience Portfolio at Medtronic, said in a press release. "We remain completely committed to our sacral neuromodulation portfolio because this option is, and will continue to be, the best choice for many patients. Implantable TNM aims to be an extension of our belief that choice matters. No two patients are the same and their therapy should not be either."