The request came as a premarket notification — also known as a 510(k) — which is an application to the FDA showing that the proposed device is at least as safe and effective as a legally marketed and similar device or method.
A lung transplant is considered the gold standard therapy for patients with pulmonary failure as a consequence of underlying lung diseases, including pulmonary fibrosis (PF) and chronic obstructive pulmonary disease (COPD). The procedure helps to extend a patient’s life and improve its quality.
Standard practices for a lung transplant today involve packaging the donor lungs in sterile bags and storing them on ice in a cooler.
Paragonix Technologies’ LUNGguard Donor Lung Preservation System allows for thermal and physical protection of lungs during transportation, from the point of being harvested from the donor up until transplant in a patient.
The system allows static transport at very low temperatures (hypothermic storage), with a controlled temperature range to maintain a stable temperature across the donated lung, the company states. LUNGguard is also equipped with data reporting, by measuring and continuously displaying organ temperature during transport, allowing careful monitoring by healthcare professionals.
“Donor lungs for transplant are fragile, precious cargo that are by necessity packaged and transported over great distances. Quality management and control over the environmental conditions of the donor lung is critical to the success of the operation,” Matthew Hartwig, MD, a lung transplant surgeon at Duke University Lung Transplant Program, said in a press release.
The recommended storage time with LUNGguard is up to eight hours.
According to Paragonix, LUNGguard can be used with any FDA-cleared solution to preserve the lungs, and in accordance with United Network for Organ Sharing (UNOS) guidelines. The system is expected to be available in the U.S. this spring.
“Patients on the lung transplant waitlist must be given every possible advantage in their journey of becoming a lung transplant recipient,” said Jeff Goldstein, CEO of the Lung Transplant Foundation. “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 Technologies specializes in the development and marketing of organ care and transportation devices.
According to the Organ Procurement and Transplantation Network, 2,400 lung transplants were performed across the U.S. in 2016.
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