U.S., Nov. 22 -- ClinicalTrials.gov registry received information related to the study (NCT07243197) titled 'DragonFly M2 Pivotal Study' on Nov. 17.
Brief Summary: To confirm the effectiveness and safety of the DragonFly M2 Transcatheter Mitral Valve Repair System for the treatment of symptomatic moderate-to-severe (3+) or severe (4+) degenerative mitral regurgitation in high surgical risk subjects.The safety and effectiveness of the first-generation device(Dragonfly Transcatheter Mitral Valve Repair System)have been previously demonstrated. This study aims to further confirm the safety and effectiveness of the new device following structural optimization based on the first-generation design.
Study Start Date: Jan. 15, 2026
Study Type: I...