Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility

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 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 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 10 hours
• EVLP 6 hours
• CIT-2 6 hours for first lung or > 10 hours for second lung
• or Study Center investigator deems lung function unsuitable for intended subject