Paragonix Technologies said today that the FDA granted 510(k) clearance for a design change to its SherpaPak heart transport device so that it can be used with small and pediatric hearts.
Braintree, Mass.-based Paragonix said it will begin shipping heart connectors covering most aortic diameters during the first quarter of 2019.
“This FDA clearance is an important milestone in making the Paragonix SherpaPak CTS accessible for all donor populations, increasing the market reach of this important transplant product,” chairman & CEO Bill Edelman said in prepared remarks. “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 make this a reality.”
Paragonix won won 510(k) clearance from the FDA in December 2014 for the SherpaPak heart device and landed CE Mark approval in the European Union in February.