23
May
2023
Patient inclusion completed in European clinical trial with XVIVO’s heart preservation technology
XVIVO’s innovative heart technology is currently under investigation in a randomized controlled clinical trial across 15 leading transplant centers in 8 European countries. 202 patients have gone through a transplantation in the trial which means inclusion is now completed of all planned participants. The next step is a one-year follow-up phase where patient outcome will be collected and monitored before the trial is closed and data presented. However, the pre-work for initiation of the product approval process has already started and dependent on passing MDR (Medical Device Regulation) requirements, a CE mark can be expected in the first half of 2024.
Read more