Med-Tech Innovation News spoke to Dr. Lisa Anderson, CEO of Paragonix, about its SherpaPak solution which allows for the safe transportation of organs prior to transplants.
Tell us about your innovation – what went into its creation?
Paragonix was conceived in response to our surprise at the lack of innovation in donor organ transport in the last 50 years. The standard of care, ice storage, had not changed since the inception of organ transplant in the 1960s. We determined there was a need for a more scientifically reproducible, measurable, and reliable solution to transporting an organ from a donor to recipient. We set out to create a new standard for organ preservation and transport that would provide the care and quality of handling commensurate with transporting such a valuable gift and improve patient outcomes worldwide. Paragonix has been developing these novel donor organ preservation and transport systems since 2012. In 2018 we realised the first step in our vision, launching Paragonix SherpaPak Cardiac Transport System for Donor Heart preservation in, and to date have preserved over 900 donor hearts worldwide.
How is it made? What materials did you use, and who did you work with to develop it?
Our devices are made from a series of interconnected systems which work together to provide a consistently cool, 4-8°C, sterile environment for the preservation and transport of the heart. The innermost portion is a sterile pair of nested polycarbonate cylinders which contain the heart and appropriate preservation solution and allows for safe handling of the heart following recovery and allow monitoring of preservation solution temperature in real time. These cylinders are surrounded by a series of proprietary phase change material pouches which help to keep the heart cool during storage and transport. These components are in turn housed in a wheeled outer shipper device that works to protect and insulate the inner contents as well as displaying solution temperature.
How are organs preserved to ensure they are not damaged?
Paragonix incorporates clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide physical and thermal protection. The Paragonix SherpaPak Cardiac Transport System (CTS) is a new technology designed to prevent freezing and establish a regulated standard in the procurement process—where there has otherwise been none. Paragonix SherpaPak CTS is leading FDA cleared and CE marked transport device for heart transportation. Additionally, the Paragonix SherpaPak can connect with the Paragonix App to provide real-time information related to temperature and location, as well as a communication platform for the transplant teams.
Where is the device currently available?
The Paragonix SherpaPak is currently FDA cleared for use in the United States and CE marked and cleared for use in Germany, Austria, England, Ireland, Italy, and Spain.
Any future plans or further developments to tell us about?
Paragonix has FDA cleared and CE marked medical devices for the transport and preservation of donor lungs, pancreases, kidneys, and livers, all designed to improve donor organ quality and extending donor organ transport time. Moving forward we are developing perfusion and pressure regulation technologies designed to enhance the performance of our heart and lung devices.
