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GOTHENBURG, SE / ACCESSWIRE / November 25, 2024 / XVIVO Perfusion AB (STO:XVIVO)(LSE:0RKL)(FRA:3XV) XVIVO's innovative heart technology is currently under investigation in the US clinical trial "PRESERVE: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors." This marks the enrollment completion of the Investigational Device Exemption (IDE) trial which was intended to enroll patients at an ambitious pace of 18 months, but was instead completed in 13 months - 5 months ahead of schedule. To date, 141 patients have undergone transplantation with the XVIVO heart technology at 14 leading heart transplant hospitals in the US. The next milestone will be one year follow-up, where patient outcomes will be collected and monitored before the data is analyzed and presented to the US Food & Drug Administration (FDA) via the Pre-Market Approval (PMA) process.
The United States is the world's largest heart transplant market, with approximately 4,500 heart transplants performed in 2023. 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 Igelösa LifeScience in Sweden, the XVIVO heart device and proprietary solution are designed for preservation of donor hearts using Hypothermic Oxygenated Perfusion (HOPE). The PRESERVE multicenter clinical trial is intended to evaluate the safety and effectiveness of the XVIVO heart technology to support a PMA Application to the FDA. Amongst other inclusion criteria, the trial allows transplant centers to include donor hearts from older donors (defined as aged 50 years old or above), Donation after Circulatory Death (DCD), and from long-distance donors.
The shorter inclusion time reflects the enthusiasm and commitment of trial centers to evaluate the ability of cold, oxygenated technology to make more hearts available for transplant. This has been made possible by the dedication of the XVIVO clinical team to ensure trial sites were provided 24/7 support, resulting in strong momentum throughout the 13 months.
"We are excited about the potential of the XVIVO heart preservation system to transform heart transplantation. By providing controlled moderate hypothermia and oxygenated low-pressure perfusion during storage and transport, the system mitigates ischemia and its negative effects. This technology not only expands the donor pool by making higher-risk hearts viable but also enhances patient safety during logistical challenges such as long-distance transport or surgical delays. Anecdotally, we've observed improved heart function post-transplant, with patients often weaning from bypass with minimal support. We eagerly await the detailed analysis of the PRESERVE trial data to validate these promising outcomes with rigorous scientific evidence", says Dr. Victor Pretorius, MBChB - National PI, UC San Diego Health, the US*.