Karten Design Partner Axonics Modulation Technologies Wins CE Mark Approval

Karten Design is excited to announce that our partner Axonics Modulation Technologies recently received a Conformité Européenne (CE mark) for the world’s first rechargeable implantable sacral neuromodulation system (SNM). With this news, Axonics is enabled to market its SNM system throughout the European Union as it now meets the requirements of all European medical device directives.

Karten Design worked in close alignment with Axonics to design, develop, and fully validate the cutting-edge system in less than 30 months. Our teams employed design strategy, in-depth user research, and evaluative testing to develop a revolutionary product that significantly enhances the user experience for both clinicians and patients.

Axonics’ SNM system is comprised of a miniaturized, rechargeable implant, a digital clinician programmer, and a patient charger and remote. The neurostimulation therapy is used to treat overactive bladder, urinary retention, and fecal dysfunction, conditions that affect hundreds of millions of people in the US and Europe alone.

Read the announcement here, or click here for the story behind the system’s design.