Karten Design Partner Axonics Modulation Technologies Announces First Patients Treated and Receives MRI Conditional Labeling Approval

Karten Design is excited to announce that our partner Axonics Modulation Technologies, developer of the world’s first rechargeable implantable sacral neuromodulation system (SNM), recently received magnetic resonance imaging (MRI) conditional labeling approval in Europe. Now, patients who are receiving neurostimulation therapy through Axonics’ SNM System are safely cleared to undergo head and neck MRI scans in 1.5 Tesla and 3 Tesla environments. Click here to read more.

In addition, Axonics announced that its first patients were successfully implanted with the SNM system as part of its RELAX-OAB 65-patient post-market clinical follow-up study. This news comes as the Axonics SNM System received CE Mark in early June. The study, which is taking place at leading medical centers in England, Belgium, the Netherlands and France, is focused on analyzing the performance of the Axonics SNM System in treating overactive bladder as well as capturing quantitative metrics. Read more about the follow-up study here.

Karten Design played an instrumental role in the design of the patient and physician-facing elements of the Axonics System including a key fob sized wireless remote and charging device that allows patients to easily communicate and recharge the implanted neuromodulator that delivers small electrical bursts to the sacral nerve in the body to treat urinary and fecal dysfunction.

Another major contribution was both the physical and user interface design of a bespoke handheld tablet device that is used by clinicians in the operating theatre to program the implantable neuromostimulator.

According to Axonics CEO, Raymond Cohen, Karten's involvement from onset of the project was one of the keys to raising nearly $60 million for this project. Before starting product development, Karten conducted in-depth user research and human factors testing that led to implementing a design strategy that significantly enhances the user experience for both clinicians and patients.

To learn more about system’s design, click here.