The launch of the PRESERVE Continued Access Protocol (CAP) study marks a significant advancement in organ transplantation, ensuring U.S. patients awaiting heart transplants can continue to benefit from the XVIVO Heart Assist Transport system. Following the success of the pivotal PRESERVE trial, this FDA-approved CAP study allows XVIVO to maintain clinical use of its portable heart perfusion technology while gathering critical long-term data for its Pre-Market Approval (PMA) application. With enrollment now underway at 26 transplant centers and continued cost recovery approval from the Centers for Medicare & Medicaid Services (CMS), XVIVO is helping bridge a critical care gap for patients and providers alike.

Designed to preserve donor hearts in a near-physiologic state during transport, the XVIVO Heart Assist Transport device offers a transformative solution to the limitations of traditional cold storage. By enabling longer travel times and enhanced organ assessment, the system can increase donor organ utilization and improve transplant outcomes. The CAP study not only supports uninterrupted access to this cutting-edge technology, but also ensures that high-quality safety and efficacy data continues to be collected in alignment with the original PRESERVE trial. This continuity reinforces both clinical confidence and regulatory rigor as the device moves toward potential market approval.

Looking ahead, the CAP study represents a strategic step forward in XVIVO’s broader vision of reducing waitlist mortality and expanding access to viable donor organs. With strong support from transplant centers and federal agencies, the Heart Assist Transport platform is well-positioned to play a pivotal role in reshaping the standard of care in heart transplantation. As the company prepares for its PMA submission, the ongoing use and evaluation of this device underscore its growing value in the field-and its potential to significantly improve survival rates for patients across the U.S.