The clearance follows the company’s completion of the pivotal PRESERVE clinical study, which enrolled 121 patients across 17 sites and was completed in collaboration with the Society of Urologic Oncology Clinical Trials Consortium.

According to the company, the study demonstrated the system’s safety and effectiveness, with 84% of patients free from clinically significant in-field disease at 12 months post-procedure. Additionally, the study reported favorable quality-of-life outcomes, including short-term urinary continence preservation and minimal reduction in erectile function.