XVIVO to file heart-preservation device for FDA approval after PRESERVE trial hit
XVIVO plans a PMA submission in the second half of 2026 built on PRESERVE Trial results showing 92.1% treatment success at Day 30 and 91.4% survival at Day 365 in extended-criteria donor hearts.
Executive Summary
- XVIVO's pivotal trial of its heart preservation and transport system met both of its registered primary endpoints, clearing the performance bars the company set for effectiveness and survival.
- The company plans to convert that result into a formal U.S. approval filing this year, a procedural step that follows directly from the trial's outcome rather than a new data event.
- The technology targets hearts from older or higher-risk donors that transplant centers often decline today because of preservation time limits, an unmet need the trial was designed to address.
- Machine perfusion for donor hearts has one established device precedent; the filing would put XVIVO's system up against that comparator's clinical position rather than into an open field.
What XVIVO disclosed
XVIVO announced on April 22, 2026 that its PRESERVE Trial (NCT05881278) met its pre-specified primary endpoints for hypothermic oxygenated perfusion (HOPE), a cold, oxygenated organ-preservation method delivered through the XVIVO Heart Assist Transport system. The trial enrolled 141 transplant recipients across 14 U.S. centers between October 2023 and November 2024, evaluating extended-criteria donor hearts, those from older donors or donors with risk factors that often keep organs off the transplant list. XVIVO said it intends to submit these results to the FDA as part of a Pre-Market Approval process, the device-approval pathway for high-risk devices, in the second half of 2026. Late-BreakingLate-Breaking Data from PRESERVE Trial Evaluates XVIVO’s HOPE Preservation Approach in Heart TransplantationApr 22, 2026
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
The endpoint results
The registered primary endpoints measured the percentage of patient survival and the percentage of treatment success. The company reported a 92.1% success rate on the primary effectiveness endpoint at Day 30, which it said exceeded the trial's pre-specified performance goal, and a 91.4% survival rate at Day 365, also above its pre-specified goal. It also reported that 73.8% of cases exceeded the traditional four-hour static-preservation window that limits which donor hearts centers currently accept. Victor Pretorius, the trial's principal investigator, said the PRESERVE results showed HOPE "being studied for the potential to support the use of extended-criteria donor hearts that can be successfully utilized for transplant". NCT05881278+1XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)NCT05881278Late-Breaking Data from PRESERVE Trial Evaluates XVIVO’s HOPE Preservation Approach in Heart TransplantationApr 22, 2026
Trial design and stability
The Not Applicable-phase designation reflects a device trial rather than a drug-development phase; the study tested a perfusion system and solution rather than a pharmacologic mechanism. The trial's primary completion date moved from an initial 2026-03-01 target to 2025-11-01 and then to 2025-11-22, a pull-in rather than a delay, while enrollment held flat at its 141-participant target throughout. The trial has been Active, not recruiting since November 2024, consistent with a study that completed enrollment and is now working through follow-up and disclosure rather than one that stalled. NCT05881278XVIVO Heart Perfusion System (XHPS) With Supplemented XVIVO Heart Solution (SXHS)NCT05881278
The competitive field
Machine perfusion for donor hearts has one established modality precedent in TransMedics' Organ Care System (OCS) Heart, which shares the same medical-device modality and heart-transplant indication as XVIVO's system, though the two use different preservation approaches. No FDA approval history or regulatory designation events were found for the XVIVO Heart Assist Transport system, so its Pre-Market Approval submission would be the first regulatory record for this specific device. Given a field with one direct device comparator already established in clinical use, a PMA submission that reproduces or extends the trial's reported success and survival rates against that comparator's demonstrated clinical position is the result that would matter for adoption.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.