XVIVO granted additional patient enrollment in the US PRESERVE CAP study for XVIVO Heart Assist Transport
XVIVO granted additional patient enrollment in the US PRESERVE CAP study for XVIVO Heart Assist Transport
XVIVO announces that the US Food and Drug Administration (FDA) has granted the company approval for additional patient enrollment in the Continued Access Protocol (CAP) study of 60 heart transplantations using XVIVO Heart Assist Transport. Last summer, XVIVO received approval to enroll up to 60 patients across 26 US transplant centers, with the final patient enrolled in March. Importantly, the study has once again received continued cost recovery approval from the Centers for Medicare & Medicaid Services (CMS), providing essential access and support for both participating centers and patients.
The CAP trial allows for continued clinical use of the XVIVO Heart Assist Transport device while XVIVO collects and analyzes one-year follow-up data from the PRESERVE trial in preparation for submitting its Pre-Market Approval (PMA) application. The protocol closely mirrors the original IDE study, ensuring continuity in the collection of clinical data collection. The CAP trial will remain active until the FDA completes its PMA review or the maximum number of enrolled patients has been reached.
“The FDA and CMS approvals provide an important mechanism to maintain continued clinical evaluation during this interim period. We are very pleased with the strong interest from participating sites, which further reflects the continued engagement of transplant centers in the ongoing clinical evaluation of the XVIVO Heart Assist Transport,” said Christoffer Rosenblad. “Our vision is that nobody should die waiting for a new organ, and we remain committed to realizing that vision while continuing to support clinicians delivering advanced care with our heart technology.”
CAUTION—Investigational device. Limited by Federal (United States) law to investigational use. The safety and effectiveness of this device have not been established.
The XVIVO heart technology is not commercially available.
August 3, 2026
Gothenburg
Christoffer Rosenblad, CEO
XVIVO Perfusion AB (publ)