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First Sacral Neuromodulation Systems Implanted in Study
01/05/2018
The first 11 patients of a study on a novel rechargeable sacral neuromodulation system have received an implant of the treatment by Axonics Modulation Technologies (Irvine, CA). This single-arm, prospective study, titled ARTISAN-SNM, is designed to demonstrate the safety and effectiveness of the company’s innovative system for the treatment of urinary urge incontinence. The company expects to expand the study to 120 patients in 15 medical centers across the United States and western Europe. It is also designed to gain Food and Drug Administration (FDA) premarket approval as a study conducted under a FDA Investigational Device Exemption.
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