Thirty-Day Outcomes of a Dedicated Transcatheter Occlusion Device for Paravalvular Leak Closure: The PARADIGM Study

“The U.S. approval of the Amplatzer Paraclose PVL Occluder addresses a significant treatment gap for people suffering from a paravalvular leak. Its unique elliptical shape is specifically designed to effectively close a wide range of PVL shapes and sizes that allows many patients to avoid another cardiac surgery.”

“PARADIGM met its primary endpoint, with favorable short-term outcomes. The results support this transcatheter device as a promising therapeutic option for PVL closure.”

“Offering this purpose-built device fills a critical unmet need as physicians treating PVL in the U.S. previously didn't have an approved alternative to repeat open-heart surgery.”