Organ transplant preservation company Paragonix Technologies is launching the first FDA-cleared system for protecting donated pancreas tissue.
The company’s PancreasPak builds upon its previous smart cooler offerings for shepherding hearts, lungs and livers, which provide temperature-controlled environments and GPS tracking capabilities—a major step up from the use of consumer-grade ice chests.
According to Paragonix, the system is designed to hold the organ between 4 degrees Celsius and 8 degrees Celsius, just above freezing, for up to 21 hours. That temperature range is based on the company’s SherpaPak for keeping donated hearts viable, where the company’s studies have shown fewer complications after transplant and eventual improvements in patient survival.
However, the company said the delicate pancreas, compared to other organs, can be even more vulnerable to damage during transport. The PancreasPak has obtained a 510(k) clearance from the FDA, and Paragonix said it will begin shipping the system in September.
Last year, the company obtained a green light from the FDA for its pressure-controlled lung transplant system, BAROguard, which keeps the inner airways of the organ properly inflated. This aims to protect the donation from changes in air pressure—during a cross-country flight, for example—from straining and damaging the tissue.
Last December also saw Paragonix launch a transplant logistics and procurement network to complement the use of its rolling coolers, including more than 50 certified surgeons and preservation specialists and seven supply hubs in strategically placed locations across the U.S.