LUNGguard System Used for 1st Time With IPF Patient’s Transplant

The first lung transplant using LUNGguard, a cold storage device for transporting donor lungs, was performed in a person with idiopathic pulmonary fibrosis (IPF), Paragonix Technologies, the device’s developer, announced.

The first device of its kind to be cleared by the FDA, it became commercially available in both the U.S. and Europe late last year.

For this transplant surgery at Duke University Hospital in North Carolina, the device preserved the donor lungs for seven hours of storage and transport, Paragonix reports in a press release.  Since this first use, LUNGguard has been used with four other lung transplant surgeries at Duke, treating people with organ-damaging disorders that range from emphysema to cystic fibrosis.

These transplant surgeries were led by John Haney, MD, the hospital’s surgical director, and supported by Carolina Donor Services, a federally recognized organ procurement group.

“Duke Health is committed to pioneering new innovations that benefit transplant patients and changing the way donor lungs are transported has this potential,” Haney said.

“I am honored that our team could be part of the first-in-man use of the LUNGguard system and we are excited by its positive impact in lung transplantation and saving more lives,” said Danielle Niedfeldt, president and CEO of Carolina Donor Services.

Pulmonary fibrosis (PF) is among the leading causes of lung transplants in the U.S., and this procedure is often seen as the best way of improving life quality and prolonging survival in people with pulmonary failure due to PF.

However, its success depends on the quality of the donor lungs that arrive at a transplant center.

Donor organ preservation has, for decades, consisted of immersing the organs in a sterile plastic bag containing a preservation solution, placed inside bags filled with saline solution and then put inside an ice box.

As a published study noted, however, organs transported in this way often risk becoming too cold (or too warm), damaging the fragile tissue. (This 2015 study was to verify the effectiveness of  the Paragonix SherpaPak, now approved for use in transporting donor hearts, and included a Paragonix employee among its researchers.)

“Donor lungs are sensitive to injury and the current ice storage of lungs risks cellular injury, especially with the increasing transport distances and times now experienced by lung transplant centers,” Haney said.

The LUNGguard system maintains organs at very low temperatures (hypothermic storage) within a tightly controlled range during transport, from the point of harvesting through to transplant.  It is also able to measure and continuously display organ temperature during transport, allowing professionals to monitor the organ’s status in real time.

Eight hours is the recommended extent of storage using the LUNGguard system.

“At Carolina Donor Services, our mission is to maximize the passing of the heroic gift of life from one person to another through organ donation. We are constantly embracing new technologies that will help safeguard organs and ensure better outcomes for those patients waiting for the gift of life,” Niedfeldt said.

Development of the LUNGguard transport system resulted from a collaboration between Paragonix and the Lung Transplant Foundation, an advocacy group for lung transplant research.

“The LUNGguard device is a project that we have been working on with Paragonix for the past three years, because we saw the critical need for this technology in lung transplantation. To be able to help another IPF patient in the first-in-man case could not have been more significant to me personally,” said Jeffery Goldstein, the foundation’s president and founder, and a lung transplant recipient.

In addition to its lung and heart donor organ devices, Paragonix offers devices for kidney, liver, and pancreas transplants that also are cleared for use in the U.S. and EU.

“Our team at Paragonix strives to provide donor organs and transplant recipients every possible advantage for a second chance at life,” said Lisa Anderson, PhD, president and chief operating officer of Paragonix.

“We are honored to partner with the team at Duke and Carolina Donor Services to reach this incredible milestone and begin making an impact to as many lung transplant patients as possible,” she added.