Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation

Inclusion

At least one of the following:

- Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or

- Expected cross-clamp time > 6 hours for the second lung; or

- Donor after Cardiac Death (DCD donor); or

- Donor age ≥ 55 years old

Inclusion Criteria:

- Male or female primary double lung transplant candidate

- Age ≥ 18 years old

- Signed: 1) written informed consent document and 2) authorization to use and disclose
protected health information

Exclusion Criteria:

- Prior solid organ or bone marrow transplant

- Single lung recipient

- Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic
renal dysfunction requiring dialysis

- Participant in any other clinical or investigational trials/programs