Xvivo Perfusion gets FDA approbal to include DCD hearts in IDE clinical trial

The US Food & Drug Administration has approved XVIVO’s Investigational Device Exemption supplement for its heart preservation clinical trial to now include Donation after Circulatory Death hearts. This permits clinical trial sites to utilize XVIVO’s heart technology to preserve hearts from DCD donors in the PRESERVE Clinical Trial. The study is a “Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors”. The number of patients to be enrolled are 141 at up to 20 US hospitals. The number of patients are unchanged, but this change will allow for five additional clinics to participate in the trial. The United States is the world’s largest heart transplant market, with approximately 4,100 heart transplants performed in 2022. During the same year, DCD donors consisted of approximately one third of the total donor pool in the United States. With an increasing number of patients in need of a transplant, the ability to safely utilize, preserve, and transport more donated organs is critical to address the growing organ shortage. Developed in collaboration with Professor Stig Steen at Igelosa LifeScience in Sweden, the patented XVIVO heart device and proprietary solution are designed for preservation of donor hearts during transport using cold, non-ischemic perfusion. In 2022, XVIVO’s heart technology was featured in the global news as a crucial component for the success of the first xeno heart transplant that was performed at the University of Maryland in the US. The PRESERVE multicenter clinical trial will evaluate the safety and effectiveness of the XVIVO heart technology to be used in support of a Pre-Market Approval. The trial will enroll 141 patients across 20 leading transplant centers in the US. Amongst other inclusion criteria, the trial will allow transplant centers to include donor hearts from older donors, Donation after Circulatory Death donors, and long-distance donors.