Neuspera Medical has announced the first patient has been successfully implanted with the Nuvella system in its pivotal SANS-UUI clinical trial, which will evaluate the safety and efficacy of the system—designed to treat overactive bladder (OAB) with sacral neuromodulation (SNM) in patients with urinary urgency incontinence (UUI) symptoms.
This first procedure was performed by Jodi Michaels (Minnesota Urology, Saint Paul, USA), who said: “I am excited to be a part of the initial cases, and for the potential of this innovative technology to treat my OAB patients in a less invasive and more adaptable way than current devices. This system has the ability to treat UUI symptoms with the smallest available implant, significantly improving the patient experience.”
The prospective, multicentre, single-arm SANS-UUI study will enrol 145 patients globally. Feasibility-phase results were first presented at the annual meeting of the American Urological Association (AUA; 10–13 September 2021, Las Vegas, USA). In 34 patients implanted with the Nuvella system, 90% 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.
SNM is a proven therapy for the treatment of UUI that can significantly improve quality of life in patients suffering from this condition, Neuspera claims. The Nuvella system delivers neuromodulation therapy through a “wireless, less invasive and more versatile platform” than commercially available technology. The company’s press release adds that it is also the first SNM device that offers this ultra-miniaturised option, which may allow for a better patient experience and greater procedural flexibility.
“We are pleased to enrol the first patients in our pivotal SANS-UUI trial—an important milestone for the company,” said Neuspera CEO Steffen Hovard. “Kicking off enrolment builds on the strong momentum from our feasibility experience. This technology has the potential to revolutionise the way physicians utilise SNM therapy to treat patients battling chronic conditions, while restoring patients’ health and quality of life.”