Axonics’s sacral neuromodulation system gets CE mark to treat urinary and fecal dysfunction

6 June 2016 (Last Updated June 6th, 2016 18:30)

US-based medical technology company Axonics Modulation Technologies has secured the CE mark for its rechargeable sacral neuromodulation system (SNM) to treat urinary and fecal dysfunction.

US-based medical technology company Axonics Modulation Technologies has secured the CE mark for its rechargeable sacral neuromodulation system (SNM) to treat urinary and fecal dysfunction.

The SNM system is an implantable neuromodulation system which controls the sacral nerve activity to treat overactive bladders (OAB), fecal incontinence and urinary retention.

It features a miniaturised implantable pulse generator that is 60% smaller and has a durability of 15 years, three times more than the current non-rechargeable SNM technology.

"Approximately 85 million adults in the US and Europe are affected by OAB while another 40 million people suffer from fecal disorder."

The sysytem is also fitted with a key-fob sized patient-friendly remote control and an intuitive clinician programmer, which will guide and support physician implanters throughout the procedure.

University of California Riverside School of Medicine obstetrics and gynecology department chairperson Karen Noblett said: "The Axonics device promises increased patient comfort given its small size and moreover, the fact that it is rechargeable and can function three times longer in patients will eliminate the need for repeat surgeries to replace non-rechargeable devices that currently require replacement every four or five years."

A peer-reviewed study has revealed that the expenditure involved in the usage of a rechargeable SNM system with a long-lived battery is lesser than that of a non-rechargeable SNM system to treat OAB.

Approximately 85 million adults in the US and Europe are affected by OAB while another 40 million people suffer from fecal disorder.

The company's SNM therapy has proven effective and durable against the disease and has helped more than 200,000 patients to date.

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."