News Tag: English

Patient inclusion completed in European clinical trial with XVIVO’s heart preservation technology

  • 13:00

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

XVIVO’s IDE application for its innovative heart preservation technology has been approved by the US FDA

  • 05:30

The US Food & Drug Administration (FDA) has approved XVIVO’s Investigational Device Exemption (IDE) application for its´ heart preservation technology. The approval allows XVIVO to start the “PRESERVE Clinical Trial: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors”.

Read more