Axonics Modulation Technologies said today it launched the Relax-OAB 65-patient post-market clinical follow-up study of its SNM system designed to treat overactive bladder.
The SNM rechargeable neuromod system is designed to treat overactive bladder, urinary retention and fecal incontinence through sacral nerve stimulation, the Irvine, Calif.-based company said.
Axonics touted the 1st implants and enrollments in the study, which took place at London’s National Hospital for Neurology and Neurosurgery and the Netherlands’ Maastricht University Medical Centre.
“This miniaturized rechargeable SNM System represents a major step forward for patients seeking a long-term solution to relieve overactive bladder symptoms and improve their quality of life. The implant is expected to be functional for at least 15 years in the body, which is more than 3 times longer than current non-rechargeable systems,” Philip van Kerrebroeck, who performed 3 initial implants in the study, said in a press release.
The SNM system won CE Mark approval in the European Union earlier this month, and the study aims to analyze the performance of the system in treating the symptoms of Overactive Bladder.
“The implantation procedure of the Axonics system was quick and easy and consistent with our current Sacral Neuromodulation implant practices. Our patients are excited to have the option of an implant with such a small size and long life. We will closely follow the patients and are confident they will experience significant relief of their overactive bladder symptoms,” Dr. Sohier Elneil, who performed the 1st implant in the study, said in a prepared statement.
Earlier this month, Axonics announced the publication of a cost-efficacy study of the device in the journal Neurourology and Urodynamics.
Newly published data from a study of the device, which aimed to assess cost savings to U.S. healthcare payers through the use of the system, indicated a possible savings of more than $12 million over the next 15 years, the company said.