OCS™ Lung TOP Registry

This is an all-comers registry that will enroll minimum of 500 double lung transplant
recipients transplanted with donor lungs preserved using the OCS™ Lung System. All consented
subjects who receive OCS™-preserved double lung transplants will be approached for
participation. When a matching donor lung is identified for a PAS consented recipient, it
will be evaluated for eligibility. The registry will evaluate short and long-term safety and
effectiveness of the OCS™ Lung System for lung transplantation in a real-world environment

Inclusion Criteria (Donor):

- Donor age < 65 years old.

- Normal gas exchange PaO2/FiO2 ratio ≥ 300 mmHg at final acceptance of donor lungs

Exclusion Criteria (Donor):

- Positive serology (Hepatitis B, Hepatitis C, HIV)

- Presence of moderate to severe traumatic donor lung injury such as: pneumo/hemothorax
or lung contusion seen on chest X-ray, CT scan, visual inspection, or bronchoscopy

- Presence of active pneumonia or lung infection, or structural lung disease (e.g.,
masses, COPD bullae, or infarcts)

- Donor after circulatory death (DCD donor)

Inclusion Criteria (Recipient)

- Male or female primary double-lung transplant candidate who receives a standard
criteria donor lung perfused on the OCS™

- Age ≥ 18 years old

- Signed: written informed consent and authorization to access and disclose protected
health information

Exclusion Criteria (Recipient)

- Single lung transplant recipient

- Prior solid organ or bone marrow transplant

- Multi-organ transplant recipient

- Chronic use of hemodialysis or diagnosis of chronic renal failure requiring dialysis