Posted by Michael Wonder on 04 May 2022
X-Therma receives FDA breakthrough device designation for XT-ViVo preservation solution and TimeSeal organ transport device
3 May 2022 - X-Therma announced today that the Center for Devices and Radiological Health of the FDA has granted its proprietary organ preservation solution, XT-ViVo and TimeSeal Organ Transport Device, breakthrough device status.
XT-ViVo is a novel organ preservation solution indicated for perfusion and flushing of a donor's kidney prior to removal from the donor or immediately after removal from the donor. The solution is left in the organ vasculature during hypothermic storage and transportation to the recipient.
