FDA clears Paragonix’s pediatric donor heart transport system

The SherpaPak is designed to maintain a safe temperature evenly across the donor organ, indicated for up to 4 hours of use. (Image: Paragonix)

The FDA has cleared a new insulated organ transport system designed for shepherding small and pediatric hearts from donors to transplant recipients.

The latest version of Paragonix Technologies’ SherpaPak Cardiac Transport System includes connectors covering most aorta sizes, allowing both adult and pediatric hearts to be carried in its proprietary suspension system.

The company said the upgraded product will begin shipping in the first quarter of 2019. The single-use SherpaPak system is the only FDA cleared and CE marked system for donor heart transport and storage.

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It’s designed to maintain a safe preservation temperature evenly across the donor organ, between 4 and 8 degrees Celsius, compared to the traditional use of uncontrolled ice chests and coolers.

While the storage temperature has been validated for more than 12 hours in various environments, according to Paragonix, its FDA 510(k) clearance is indicated for up to four hours of use. The device is currently marketed in the U.S., United Kingdom, France, Spain, Italy, Germany, Austria and Slovakia.

“Our goal is to establish a new standard of care for donor organ preservation and with our FDA-cleared and CE-marked devices for both heart and kidney organ stage and transport, we are on our way to making this a reality,” said Bill Edelman, Paragonix’s chairman and CEO.

The company’s donor lung transport system and active heart preservation system, providing oxygenated perfusion, are not yet available in the U.S.