Axonics submits data to FDA for marketing approval of r-SNM System

Axonics announced the submission of pivotal clinical data from the ARTISAN-SNM pivotal clinical study designed to gain marketing approval from the FDA for the Axonics r-SNM System. The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an FDA Investigational Device Exemption, or IDE, to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction. The study was conducted in 14 centers in the U.S. and 5 centers in Western Europe. All patients reached their six-month, post-implant primary endpoint in January. As the company announced on February 19, the clinical study demonstrated that patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in Urinary Urgency Incontinence symptoms and quality of life. Additionally, the study met all primary and secondary endpoints. No serious device-related adverse events have been reported. The clinical study report, or CSR, was submitted to the FDA on February 21 as an amendment to the company’s premarket approval application. The CSR provides safety and efficacy results and a detailed analysis of the full cohort of all implanted patients at the six-month post-implant endpoint.

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