Paragonix Technologies has announced European approval for Paragonix SherpaPak™ Cardiac Transport System1,2 and SherpaPerfusion™ Cardiac Transport System3,4 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.
Dr. Steven Tsui, Director of Transplantation & Mechanical Circulatory Support and Consultant Surgeon at the Royal Papworth Hospital, UK, commented “I am excited about the European availability of Paragonix’s two innovative donor heart preservation devices. I believe that the SherpaPak™ Cardiac Transport System addresses the shortcomings of current cold storage by improving temperature maintenance and monitoring of the donor heart during transport. As a heart transplant surgeon with over a decade’s experience of ex-vivo donor heart perfusion, I also welcome the addition of SherpaPerfusion™ Cardiac Transport System to the clinical community, utilizing oxygenated hypothermic perfusion for improved donor heart quality. I look forward to both products entering the clinic.” - Business Wire