FDA Approves XVIVO's Inclusion of DCD Hearts in IDE Clinical Trial
Wednesday, July 26, 2023
XVIVO Perfusion AB (STO:XVIVO)(LSE:0RKL)(FRA:3XV) has received approval from the US Food & Drug Administration (FDA) to include Donation after Circulatory Death (DCD) hearts in its heart preservation clinical trial, known as the PRESERVE Clinical Trial. This approval allows clinical trial sites to use XVIVO's heart technology to preserve hearts from DCD donors. The study, called "Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors," will enroll 141 patients at up to 20 US hospitals. Although the number of patients remains the same, this update will allow for five additional clinics to participate in the trial.
The United States has the world's largest heart transplant market, with approximately 4,100 heart transplants performed in 2022. DCD donors accounted for about one-third of the total donor pool in the country during the same year. As the number of patients in need of transplants continues to rise, the ability to safely preserve and transport more donated organs becomes crucial to address the growing organ shortage. XVIVO's heart device, developed in collaboration with Professor Stig Steen at Igelösa LifeScience in Sweden, and its proprietary solution are designed for the preservation of donor hearts during transport using cold, non-ischemic perfusion. In 2022, the global news highlighted XVIVO's heart technology as a crucial component in the success of the first xeno (pig to human) heart transplant performed at the University of Maryland in the US.
The PRESERVE multicenter clinical trial aims to evaluate the safety and effectiveness of XVIVO's heart technology for potential Pre-Market Approval (PMA). The trial will enroll 141 patients across 20 leading transplant centers in the US. Among other inclusion criteria, the trial will allow transplant centers to consider donor hearts from older individuals (defined as aged 50 years old or above), Donation after Circulatory Death donors, and long-distance donors.
Christoffer Rosenblad, CEO of XVIVO, expressed enthusiasm about the inclusion of DCD hearts in the US clinical trial, particularly considering that DCD donors make up almost one-third of the total donor pool. Additionally, the opportunity to involve up to 20 clinics will expand access to this innovative heart technology, ultimately supporting US patients with end-stage heart disease and their healthcare providers, in pursuit of their vision that "no one should die waiting for an organ."
