Novel Lung Trial
Normothermic Ex Vivo Lung Perfusion (EVLP) as an Assessment of Extended/Marginal Donor LungNovel
The safety of perfusing extended donor lungs using the XPS with STEEN solution Perfusate prior to transplantation to evaluate and recondition donor lungs and thereby safely increase the donor lung pool. This is an amendment and extension of the NOVEL trial to satisfy the (HDE) post approval study (PAS) and PMA study requirements. This data will be used to support post approval safety monitoring and in support of PMA submission.