The BAROguard system received 510(k) clearance from the FDA in August 2023. Credit: mi_viri via Shutterstock.

Paragonix Technologies has announced the complete commercial availability of its BAROguard Donor Lung Preservation System in the US.

Available to transplant centres and organ procurement organisations across the country, the device is designed to maintain donor lungs in optimal conditions during transport to provide protection.

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The BAROguard system, which received the US Food and Drug Administration’s (FDA) 510(k) clearance in August 2023, employs hypothermic preservation techniques combined with active airway management control.

This ensures maximum protection for donor lungs by maintaining the necessary preservation conditions throughout procurement.

The system is available in the US for clinical use.

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Paragonix Technologies CEO and president Dr Lisa Anderson said: “The commercial launch of BAROguard represents a significant breakthrough for the organ transplantation industry.

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“We are immensely pleased with the success it has already achieved, and we are excited to offer this game-changing technology nationwide to help transplant surgeons and their teams to innovate the standard of care in transplantation.”

During its limited market release, the system had high demand and received positive feedback. It was used by several thoracic transplant centres, including Duke Health, Johns Hopkins Medicine, Massachusetts General Hospital, UCSF Health, and UCLA Health.

The first use of the BAROguard system in a human transplant case took place at Duke University Medical Center in November 2023.

The system kept the donor lungs safe and monitored them for more than six hours during their transportation for a life-saving transplant.

Paragonix said the data collected from the BAROguard device’s commercial use will contribute to the GUARDIAN-Lung trial, a post-market observational registry which is intended to evaluate the outcomes of patients who have donor lungs preserved with the company’s devices against other methods of storage.