OCS Lung System EXPAND II Trial

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

To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria 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