XVIVO announced the filing of an Investigational Device Exemption (IDE) application to the US Food & Drug Administration (FDA). It will support an initial FDA regulatory approval to conduct the “PRESERVE Clinical Trial: A Prospective, Multi-center, Single-Arm, Open-Label Study of Hearts Transplanted after Non-Ischemic Heart PRESERVation from Extended Donors”.

This is being done under the previously announced FDA Breakthrough Designation granted for the XVIVO heart technology which is a Non-Ischemic Heart Preservation (NIHP) device. In pre-submission meetings, XVIVO worked constructively with the FDA to discuss questions and concerns and has used FDA’s feedback to determine the path forward for its IDE application. An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data that XVIVO will use in support of a Pre-Market Approval (PMA).

In 2019 there were 112,000 Americans on the national transplant waiting list while only 39,718 transplants were performed. With a growing organ shortage, the importance of preservation of available organs is magnified. The XVIVO heart technology is designed for preservation of donor hearts during transport using cold, non-ischemic perfusion for use in transplant surgery. Read more here.