Of the 1,400 patients currently awaiting lung transplantation in the U.S., nearly 200 patients will not receive a transplant in time. With approximately 400,000 new cases of end-stage lung disease diagnosed annually, the need for expanding the deceased lung donor pool is vital.

The number of lung transplants in the U.S. hovers around 2,000 per year, primarily due to the limited number of suitable donors. When lungs are procured, only about 22 percent are utilized because of the inability to identify a recipient in time, infection or inflammation, or conditions resulting from donor candidates maintained on a ventilator for days.

Located in Silver Spring, MD, Lung Bioengineering (LBE), a division of United Therapeutics Corp., is the only stand-alone ex vivo lung perfusion (EVLP) facility in the world. LBE has the potential to double the number of lungs available for transplant in the U.S. over the next five years.

By taking lungs that would otherwise be unacceptable for transplant and performing EVLP, LBE projects a return of 67 percent of the lungs for transplant. LBE’s protocol allows for lungs to be maintained outside of the donor for up to 22 hours, much longer than the current standard of around six hours from the time of surgical removal.

IIAM provides nontransplantable human lungs to the LBE team for EVLP training and education opportunities through technology developed and published by Drs. Keshavjee, Cypel and Waddell at Toronto General Hospital’s Department of Transplant Surgery. The EVLP procedure is currently approved by Health Canada; LBE continues to move toward FDA premarket approval through eight enrolled clinical trial sites, with plans to expand to 16 locations in the eastern U.S.

“Ultimately, EVLP may make it possible for surgeons to transplant lungs that were once thought unsafe to transplant,” said Richard Pietroski, President of Lung Bioengineering. “We are grateful for the service that IIAM provides to the OPO and scientific community as the bridge leading to new developments in healthcare.”

Formerly a coordinator for an OPO, Sam Popa, Certified Ex Vivo Lung Specialist at Lung Bioengineering, has a unique perspective on the benefits of working with IIAM. He said, “IIAM’s expertise in every area frees us to do our work without worry. Their large network of OPO partners nationwide provides great access to lungs, and their screening capabilities ensure that the organs meet our specific inclusion/exclusion criteria.” Popa noted that IIAM keeps LBE up to date on all communications with the OPOs that provide the lungs and coordinates all aspects of transportation to meet LBE’s timetables.

“With so many interactions between us, we’ve built a great relationship, and we value our ongoing partnership with IIAM,” said Popa.