FDA Clears LUNGguard for Donor Lung Preservation System

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Paragonix announced clearance of a Pre-Marketing Notification (510(k)) with the US Food and Drug Administration (FDA) for its Donor Lung Preservation System – LUNGguard1,2. The Paragonix LUNGguard Donor Lung Preservation System is intended to be used 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. The intended organ storage time for LUNGguard is up to 8 hours. Donor lungs exceeding clinically accepted static hypothermic preservation times should be evaluated by the transplant surgeon to determine transplantability in accordance with accepted clinical guidelines and in the best medical interest of the intended recipient.3

LUNGguard is designed to function with ease in the often extremely stressful, fast-paced environments of donor and transplant centers. The current standard-of-care for donor lungs is to package the lungs in a series of sterile bags placed on crushed ice without the ability to maintain, monitor and report environmental conditions of the organ. LUNGguard is designed to overcome current preservation limitations and provide reporting of preservation and transport data. LUNGguard will be commercially available to all US lung transplant centers in Q2 of 2020.

“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,” commented Matthew Hartwig, MD, lung transplant surgeon at Duke University Lung Transplant Program. “We are looking forward to evaluating this innovative technology in clinical practice and implementing additional quality management over the donor lung transport process using LUNGguard.”

“Patients on the lung transplant waitlist must be given every possible advantage in their journey of becoming a lung transplant recipient,” commented 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.”

“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,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “We are thrilled to contribute to improved lung preservation with LUNGguard.”


References

1On January 16, 2020, FDA cleared for commercial distribution the SherpaPak™ Lung Preservation System 510(k) pre-market submission.
2Patents pending.
3Partial lungs can be transported via the LUNGguard Donor Lung Preservation Device by packaging lungs per institutional protocol and UNOS guidelines.
4Thorac Dis. 2010 Jun; 2(2): 111–116.
5Orphanet J Rare Dis. 2008; 3: 8.
6http://www.who.int/respiratory/copd/burden/en/
7https://optn.transplant.hrsa.gov/data/view-data-reports/national-data/
8http://www.transplants.org/faq/how-much-does-transplant-cost
9Milliman Research Report, “2014 US Organ and Tissue Transplant Cost Estimates and Discussion”

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