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Home » Paragonix wins FDA clearance for next-gen lung preservation system

Paragonix wins FDA clearance for next-gen lung preservation system

August 24, 2023 By Sean Whooley

Paragonix Technologies BAROguard lung preservation system
The BAROguard lung preservation system. [Image courtesy of Paragonix Technologies]
Paragonix Technologies announced today that the FDA granted clearance for its next-generation BAROguard donor lung preservation system.

BAROguard combines Paragonix’s existing advanced hypothermic preservation technology with automated continuous and active airway pressure control. This ensures that the system maintains an optimal temperature range and a clinically recommended inflation pressure range. It maintains this for donor lungs throughout the journey from donor to recipient patient.

According to a news release, current practice sees donor lungs preserved and transported from an inflated state between donor and recipient. However, current organ recovery techniques fail to reliably maintain and control inflation pressures. Dr. Lisa Anderson, Paragonix president and CEO, said BAROguard addresses these issues with an automated, easy-to-use pressure management system.

“At Paragonix, we believe that transplant surgeons should have maximum control over the organ transplant process,” Anderson said. “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.”

A ‘significant advancement’ from Paragonix

Dr. Jack Haney added that maintaining a consistent donor lung airway pressure can help optimize static preservation. This especially rings true when recovering organs over extended times or distances. Haney serves as the surgical director of the Lung Transplant Program at Duke Medical Center. He also served as principal investigator for the company’s GUARDIAN registry.

“BAROguard offers the potential for significant advancement of lung preservation that we will be studying via the GUARDIAN registry,” Haney said.

The GUARDIAN registry also evaluated Paragonix’s LUNGGuard against conventional ice-cold storage. The Cambridge, Massachusetts-based company’s study used real-world, multi-center data. In April, Paragonix said it demonstrated a favorable influence from advanced lung preservation technology on post-transplant outcomes.

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Respiratory, Transplants Tagged With: Paragonix Technologies

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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