Today, at the 2024
The results showed that the primary endpoint, representing severe complications after heart transplantation, was registered in 18.8% of the subjects who received a donor heart preserved with the
The rates of severe primary graft dysfunction (PGD) after heart transplantation were also lower for patients who received a donor heart preserved with the
"This trial represents a significant evolution in donor heart preservation," says
"The NIHP2019 trial is the result of many years of hard work and collaboration, marking one of the greatest achievements in the history of XVIVO. It brings us one step closer to realizing our vision that nobody should die waiting for a new organ. Currently, only 30 percent of available donated hearts are utilized for transplantation - that needs to change. Our heart technology demonstrates XVIVO’s dedication as a research-driven and innovative company committed to changing the paradigm in heart preservation," says
The NIHP2019 trial is a randomized, controlled, open label, multicenter clinical investigation of the
In the US, XVIVO has obtained Investigational Device Exemption (IDE) approval by FDA for a heart preservation trial (PRESERVE) to collect the safety and effectiveness data required to support future PMA applications. Recruitment in the PRESERVE trial is ongoing.
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