Paragonix Technologies has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its LUNGguard donor lung preservation system.

The LUNGguard donor lung preservation system has been developed for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. Paragonix’s system intended organ storage time is up to eight hours.

Paragonix Technologies chairman and CEO Bill Edelman said: “The recent addition of LUNGguard to our expanding portfolio of organ preservation devices serving all solid organs will provide an important tool for the transplant community.

LUNGguard works better in stressful and fast-paced environments of donor and transplant centres

Donor lungs exceeding clinically accepted static hypothermic preservation times has to be assessed by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines.

The system is designed to work effectively in stressful and fast-paced environments of donor and transplant centres.

LUNGguard will help address current preservation limitations, as well as offer reporting of preservation and transport data.

The company aims to commercialise the LUNGguard system in the second quarter of this year.

Lung Transplant Foundation CEO Jeff Goldstein said: “Patients on the lung transplant waitlist must be given every possible advantage in their journey of becoming a lung transplant recipient.

“Based on my own experience as a lung transplant recipient, technologies are critically needed that support and complement the incredible clinical effort afforded by surgical teams and Organ Procurement Organizations as well as the wonderful gift from a donor family.”

Paragonix secured the FDA 510(k) clearance for its Paragonix SherpaPak Pancreas Transport System (PTS) in January this year. PTS offers thermal and physical protection to the donor pancreas during transport from donor to recipient patients.

In April 2019, Paragonix expanded its partnership with the Lung Transplant Foundation (LTF) to develop a series of innovative technologies for improved donor lung preservation.