Subject Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

* Male or female patients
* All patients, 18 years of age or older
* Patient already on or added to the active waiting list for a single or bilateral lung transplant
* Patient or patient's representative provides informed consent for participation in the study at the time of study commencement or time of listing for transplant
* Patient or patient's representative reconfirms informed consent for the study on the day of lung transplant

Subject Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from participation:

* Patients listed for same-side lung re-transplantation
* Patients listed for multiple organ transplantation including lung and any other organ
* Patients listed for live donor lobar transplant
* Patients with HIV, active Hepatitis B/C, or Burkholderia Cepacia
* Patients not initially consented into the study prior to the time of lung transplant
* Patients in the ICU at the time of initial lung offer requiring mechanical ventilation, ECMO or other Extracorporeal life support (ECLS).

Donor Lung Inclusion Criteria for EVLP Assessment:

The donor lung must meet at least one of the following criteria to proceed with EVLP:

* At the time of the clinical evaluation, the donor PaO2/FiO2 \< 300 mmHg
* Donor received ≥ 10 units of blood transfusions
* Donation after Cardiac Death (DCD) donor
* Expected cold ischemic time \> 6 hours
* Donor age ≥ 55 years old
* Study Center Investigator requires additional assessment ex vivo and/or extended preservation time

Donor Lung Exclusion Criteria for EVLP Assessment:

The donor lung is excluded from EVLP if at least one of the following criteria have been met:

* The donor lung has confirmed pneumonia and/or persistent purulent secretions identified via bronchoscopy
* Non-persistent purulent secretions that do not clear by hour 3 on EVLP
* The donor lung has confirmed evidence of aspiration
* The donor lung has significant mechanical lung injury or trauma
* The cold ischemic time, starting at donor aortic cross clamp/ initial flush (CIT-1), required to transport the lung from the donor site to start of the EVLP procedure at SPONSOR's facility \> 10 hours

EVLP Lung Inclusion Criteria for Transplantation:

The donor lung must meet each of the following conditions post-EVLP for transplant suitability consideration by the Study Center Investigator:

* PvO2/FiO2 ≥ 350 mmHg at final EVLP evaluation time period
* and \< 15% increase from baseline value (defined as the first hour collection point) to final value of pulmonary vascular resistance (PVR)
* and \< 15% increase from baseline value to final value of peak airway pressure (PawP)
* and \< 15% decrease from baseline value to final value of static lung compliance (Cstat)
* and the total preservation time (TPT) does not exceed the following:

* the initial CIT-1 time from donor to EVLP \> 1 hour and ≤ 10 hours
* the EVLP time \> 3 hours and ≤ 6 hours
* the second CIT-2 from EVLP cool down to beginning of recipient implantation must be \> 1 hour and ≤ 6 hours for the first lung
* the second CIT-2 from EVLP cool down to beginning of recipient implantation must be \> 1 hour and ≤ 10 hours for the second lung
* and Study Center Investigator deems lung function suitable for intended subject

EVLP Lung Exclusion Criteria for Transplantation:

The donor lung is excluded from transplant inclusion if at least one of the following criteria have been met:

* PvO2/FiO2 \< 350 mmHg at final EVLP evaluation time period
* or ≥ 15% increase from baseline value to final value of pulmonary vascular resistance (PVR)
* or ≥ 15% increase from baseline value to final value of peak airway pressure (PawP)
* or ≥ 15% decrease from baseline value to final value of static lung compliance (Cstat)
* or TPT exceeds any of the following conditions:

* CIT-1 \< 1 hour or \> 10 hours
* EVLP \< 3 hours or \> 6 hours
* CIT-2 \< 1 hour or \> 6 hours for first lung or \> 10 hours for second lung
* or Study Center investigator deems lung function unsuitable for intended subject