FDA grants 510(k) clearance to lung transplant preservation system

The FDA has granted 510(k) clearance to a donor lung preservation system that keeps lungs at optimal temperatures and inflation pressures during transport, according to a press release.

The BAROguard system (Paragonix Technologies) is made up of two key components to properly preserve lungs for transplantation: hypothermic preservation technology and automated continuous and active airway pressure control that keep inflation pressures between 12 cmH₂O to 15 cmH₂O, defined as the clinical recommendation.

According to the release, this system’s ability to manage lung pressure will be especially helpful when donor lungs are transported by aircraft because of the lung pressure changes that could occur with changes in ambient pressure.

Researchers will be using the GUARDIAN registry to study the impact of this preservation system, as indicated in the release.

“At Paragonix, we believe that transplant surgeons should have maximum control over the organ transplant process,” Lisa Anderson, PhD, Paragonix CEO and president, said in the release. “BAROguard now offers automated active control over donor lung airway pressures and automated donor lung temperature control, both of which are continuously reported out in real-time to the transplant team. The FDA clearance of BAROguard is a major step in providing transplant teams with leading technology to enhance organ transplantation outcomes.”