US-based Axonics Modulation Technologies has received CE mark approval for its sacral neuromodulation system (SNM) to treat urinary and fecal dysfunction.
The approval has been granted for the SNM system to treat overactive bladder (OAB), fecal incontinence and urinary retention.
SNM is an implantable neuromodulation system, which regulates sacral nerve activity for the management of urinary and fecal dysfunction.
It features miniaturized implantable pulse generator that is 60% smaller and expected to last for 15 years.
In addition, the system includes key-fob sized patient-friendly remote control and clinician programmer, which will guide and support physician implanters during the procedure from lead placement to programming.
The company has also secured ethics committee approval from select centers in Western Europe to commence a 65-patient post-market clinical follow up (PMCF) study.
Axonics CEO Raymond Cohen said: "Axonics has successfully developed a unique product to deliver SNM therapy that we believe will greatly improve the patient and clinician experience.
"We look forward to treating patients in our upcoming PMCF study."