Neuspera Medical recently announced it will begin enrolment in its pivotal clinical trial, SANS-UUI—a single-arm investigational device exemption (IDE) study that will enrol 145 patients at 25 sites globally.
The study will evaluate the safety and efficacy of Neuspera’s Nuvella system, which is designed to treat overactive bladder (OAB) for patients with urinary urgency incontinence (UUI) symptoms. The system is the first sacral neuromodulation (SNM) device that offers a minimally invasive option, which may allow for a better patient experience and greater procedural versatility, according to a Neuspera press release.
“We are very pleased the SANS-UUI trial has reached this important enrolment milestone, as we are now one step closer to bringing the life-changing benefits of this technology to patients,” said Alexander Yeh, founder and chief technology officer at Neuspera. “The Nuvella system is the smallest available SNM device designed to minimise post-procedure discomfort and have no visible external appearance of the implant.”
The feasibility-phase results of SANS-UUI were presented previously, the release adds. In 34 patients implanted with the Nuvella system, 90% of subjects demonstrated a 50% improvement in UUI symptoms at six and 12 months with two hours of daily stimulation, while 52% were completely dry at the 12-month visit.
“These results are very promising,” said Steven Siegel, chief medical officer at Neuspera. “In addition to the clinical benefits seen, Nuvella demonstrated safety consistent with other commercially available devices.”