Business Wire06.15.17
Axonics Modulation Technologies Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM) system for the treatment of urinary and fecal dysfunction, has announced positive initial results from its prospective, multicenter clinical study.
The results presented included outcomes for 33 subjects who have reached their three-month primary endpoint and provided significant evidence that the Axonics r-SNM system is safe and efficacious.
A total of 51 overactive bladder patients with symptoms of urinary urgency incontinence and urgency frequency were enrolled and implanted in the RELAX-OAB study. All subjects were implanted with an Axonics miniaturized rechargeable neurostimulator and did not undergo an external test stimulation typically used to screen patients. At one month, 71 percent of subjects were initial responders to therapy, defined as a 50 percent or greater reduction in incontinence or urgency frequency symptoms, or a reduction to less than eight voids per day in urgency frequency subjects.
Data at three months post-implant demonstrated:
The Axonics r-SNM System received European CE Mark approval in June 2016 and Health Canada approval in December 2016 for the treatment of overactive bladder, urinary retention, and fecal incontinence. These conditions affect over 100 million adults in the United States and Europe. SNM is a reimbursed and U.S. Food and Drug Administration (FDA)-approved therapy that has proven to be an effective and durable treatment widely used in Europe and the United States for the past two decades with more than 250,000 patients having benefited from the therapy to date.
Axonics anticipates initiating an FDA pivotal clinical study for OAB patients in select centers in the United States, Canada, and Europe in the second half of 2017.
Axonics, based in Irvine, Calif., is a privately-held venture backed company that has developed an implantable neuromodulation technology for patients with urinary and fecal dysfunction and can be further directed towards several clinical indications. The Axonics r-SNM System includes a miniaturized rechargeable stimulator qualified to function at least 15 years, an optimized charging system for limited charge time and reduced heating, a patient-friendly remote control and an intuitive clinician programmer that support the procedure from lead placement to programming.
The results presented included outcomes for 33 subjects who have reached their three-month primary endpoint and provided significant evidence that the Axonics r-SNM system is safe and efficacious.
A total of 51 overactive bladder patients with symptoms of urinary urgency incontinence and urgency frequency were enrolled and implanted in the RELAX-OAB study. All subjects were implanted with an Axonics miniaturized rechargeable neurostimulator and did not undergo an external test stimulation typically used to screen patients. At one month, 71 percent of subjects were initial responders to therapy, defined as a 50 percent or greater reduction in incontinence or urgency frequency symptoms, or a reduction to less than eight voids per day in urgency frequency subjects.
Data at three months post-implant demonstrated:
- Ninety-one percent of initial responders continued to respond to therapy
- Initial responders reported clinically meaningful improvements in quality of life, underscored by significant improvements from baseline in the ICIQ-OABqol HRQL score of 31.0 points (+/- 4.4, SE, n=23)
- More than 90 percent of initial responders were satisfied with SNM therapy provided by the Axonics r-SNM System
- There were no serious adverse device effects or unanticipated adverse device effects reported
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Two subjects (4 percent) required surgical intervention
The Axonics r-SNM System received European CE Mark approval in June 2016 and Health Canada approval in December 2016 for the treatment of overactive bladder, urinary retention, and fecal incontinence. These conditions affect over 100 million adults in the United States and Europe. SNM is a reimbursed and U.S. Food and Drug Administration (FDA)-approved therapy that has proven to be an effective and durable treatment widely used in Europe and the United States for the past two decades with more than 250,000 patients having benefited from the therapy to date.
Axonics anticipates initiating an FDA pivotal clinical study for OAB patients in select centers in the United States, Canada, and Europe in the second half of 2017.
Axonics, based in Irvine, Calif., is a privately-held venture backed company that has developed an implantable neuromodulation technology for patients with urinary and fecal dysfunction and can be further directed towards several clinical indications. The Axonics r-SNM System includes a miniaturized rechargeable stimulator qualified to function at least 15 years, an optimized charging system for limited charge time and reduced heating, a patient-friendly remote control and an intuitive clinician programmer that support the procedure from lead placement to programming.