Xvivo Perfusion AB

XVIVO Perfusion AB announced that the U.S. Food and Drug Administration has received the Premarket Approval application for the XVIVO Heart Assist Transport System. The application is supported by clinical data from the PRESERVE IDE trial, which enrolled 141 patients across 14 leading heart transplant centers in the United States, along with additional evidence from the PRESERVE Continued Access Protocol trial and clinical experience outside the United States. The PRESERVE IDE trial evaluated the safety and effectiveness of the system for the preservation and transport of extended-criteria donor hearts, including donation after circulatory death hearts and donation after brain death hearts meeting specified extended donor criteria, using Hypothermic Oxygenated Perfusion. The FDA has authorized enrollment of up to 120 patients in the CAP trial, allowing participating transplant centers to continue using the technology while the PMA application is under review. CEO Christoffer Rosenblad called the submission an important milestone and noted the recent CE certification of the XVIVO Heart Assist Transport system in Europe.