Axonics Modulation Technologies (NSDQ:AXNX) announced today that it is launching a post-market clinical registry study for its r-SNM system.
Irvine, Calif.-based Axonics’ implantable sacral neuromodulation (SNM) system is designed for treating urinary and bowel dysfunction with a battery life of 15 years or more.
The Axonics Sacral Neuromodulation System Registry (Artistry) study is a prospective, multicenter registry with plans to enroll up to 300 patients across 30 centers in the U.S. and Canada to collect and analyze real-world data from patients treated with the r-SNM system.
Patients with symptoms of urinary urgency incontinence, urinary urgency frequency, non-obstructive urinary retention and fecal incontinence will be included, according to a news release. Those subjects will help Axonics collect data on technical aspects of the procedure, effectiveness, safety and patient experience, with patients being followed over the course of one year.
“Patients with bladder and bowel dysfunction are significantly undertreated and struggle to find long-term relief,” Axonics chief medical officer Dr. Karen Noblett said in the release. “Sacral neuromodulation, which historically has been used as a therapy of last resort, is now experiencing a renaissance based on Axonics bringing new and effective technology to the market. As a result, SNM has the potential to meaningfully improve quality of life for millions of patients.
“This registry will be an important contribution to expanding the body of clinical evidence for Axonics and further demonstrate that there is a long-lived, easy-to-use, highly effective treatment available to those suffering from these debilitating conditions.”
