X-Therma’s Organ Transport System Designated an FDA Breakthrough Device

X-Therma has received a Breakthrough Device designation from the FDA for its XT-ViVo preservation solution and TimeSeal organ transport device.

The organ preservation solution is indicated for perfusion and flushing of a donor's kidney prior to removal from the donor or immediately after removal. The solution is then left in the organ during hypothermic storage and transportation to the recipient.

The TimeSeal device is designed for static hypothermic preservation of adult donor kidneys during transportation and subsequent transplantation into a recipient. The device can provide organ storage for up to 120 hours, the company said.

Richmond, Calif.-based X-Therma specializes in developing technology for regenerative medicine and organ preservation.