According to the FDA 510(k) database, the agency cleared the clip device on June 26. It marks the cardiac device giant’s entry. into the LAA device space, specifically pitting it against similar devices like AtriCure’s AtriClip and Medtronic’s Penditure system.

BTIG analysts Marie Thibault, Sam Eiber and Alexandra Pang say limited details on the Ecliptis system’s design currently exist. They note that Edwards teased the device in early December 2025 at an Investor Day event. The FDA 510(k) database shows that Edwards submitted the device for clearance just weeks later on Dec. 29, 2025.