Duke University Hospital in Durham, N.C., performed the first heart transplant in the U.S. using XVIVO?s Non-Ischemic Heart Preservation (NIHP) device and solution as part of the PRESERVE clinical trial: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors. The PRESERVE multicenter clinical trial is designed to evaluate the safety and effectiveness of the XVIVO heart technology that will be used in support of a Pre-Market Approval (PMA) with the FDA. The trial will enroll 141 patients across 20 leading transplant centers in the USA.

Amongst other inclusion criteria, the trial will allow transplant centers to include extended criteria donor hearts such as hearts from older donors (defined as aged 50 years old or above), from long-distance donors, and hearts from donation after circulatory death (DCD) donors.