Braintree, Mass.-based Paragonix Technologies, Inc. has announced European approval for Paragonix SherpaPak™ Cardiac Transport System and SherpaPerfusion™ Cardiac Transport System for application of a CE mark following review of a technical file submission by The British Standards Institution (BSI). Paragonix was issued a CE certificate by BSI for the design and manufacture of organ transportation devices for hearts and kidneys. This includes the Paragonix SherpaPak™ and SherpaPerfusion™ family of products.
The SherpaPak™ Cardiac Transport System consists of a single-use, disposable device for the hypothermic static preservation and transport of donor hearts. The SherpaPerfusion™ Cardiac Transport System consists of a single-use, disposable device for hypothermic oxygenated perfusion preservation and transport of donor hearts.
The current standard of care for donor heart preservation and transportation involves placing a heart in a series of fluid-filled sterile bags that are placed on crushed ice contained within a conventional ice chest. Unfortunately, this leads to temperatures below 2 degrees Celsius, which significantly increase the risk of cold injury and frostbite. Additionally, the current standard of care for donor heart transport limits the time an organ can be outside the body. To overcome these limitations and ensure optimal organ health following transportation, Paragonix Technologies has developed the Paragonix Sherpa™ platform of donor heart preservation devices as a powerful new technology ensuring superior organ quality during transport.