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.
“We are thrilled to have reached this milestone and anticipate significant clinical interest for both SherpaPak and SherpaPerfusion Cardiac Transport Systems. Following our commercial launch of SherpaPak in the United States, we look forward to introducing our novel donor heart preservation devices to transplant centers across Europe.”
In 2017, over 2,000 donor hearts were transplanted in Europe. In spite of significant advances in surgical technique, tissue typing, and immunosuppression, maintenance of organ quality during transport has largely been overlooked.
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 2oC 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.
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, utilising oxygenated hypothermic perfusion for improved donor heart quality. I look forward to both products entering the clinic.”
Dr. Andreas Zuckermann, Director of the Cardiac Transplantation Program at the University of Vienna, Austria, commented, “Having followed the extensive research and product development activities at Paragonix Technologies over the past few years, I am impressed by the intuitive designs of both SherpaPak and SherpaPerfusion Cardiac Transport Systems".
"They directly address all relevant issues of improving donor heart preservation at hypothermia.” Dr. Zuckermann continued, “We look forward to incorporating both donor heart preservation systems at our transplant center.”
Dr. Lisa Anderson, President & COO of Paragonix, said “We are thrilled to have reached this milestone and anticipate significant clinical interest for both SherpaPak and SherpaPerfusion Cardiac Transport Systems. Following our commercial launch of SherpaPak in the United States, we look forward to introducing our novel donor heart preservation devices to transplant centers across Europe.”