Paragonix Technologies, a leading provider of donor organ preservation and transport systems, recently launched a new donor liver preservation system (LIVERguard) and global liver registry.
The LIVERguard System provides a highly controlled, state-of-the art environment for hypothermic liver preservation, coupled with real-time digital monitoring to safeguard a donor liver throughout the transplant journey from donation to transplantation. Like all Paragonix systems, the LIVERguard System represents a fundamental advance over the use of ice and off-the-shelf coolers that have been the standard-of-care in organ transplantation for over 50 years.
Recently, on November 16, 2021, Paragonix also announced a major milestone of 1,000 preserved donor heart transports since it began clinical use in 2018 with its flagship product, the Paragonix SherpaPak Cardiac Transport System (CTS).
Four of the top five largest heart transplant programs in the United States as well as 45 other programs globally now trust the Paragonix SherpaPak System to preserve and transport critical donor hearts to their recipient donors. The Paragonix SherpaPak CTS protects donor hearts with its rigid, sterile container and maintains a temperature between 4-8ºC, a range recommended by the International Society of Heart and Lung Transplantation as an optional donor heart preservation condition. Wireless connection to a simple app gives organ environment tracking and real-time updates to the transplant team.
We had a chance to learn more from CEO and Co-Founder of Paragonix Technologies, Dr. Lisa Anderson.
Alice Ferng, Medgadget: What are the greatest issues today with organ transportation and how is Paragonix helping bridge that gap?
Dr. Lisa Anderson, CEO & Co-Founder of Paragonix Technologies: Paragonix was conceived in response to our surprise at the lack of innovation in donor organ preservation and transport in the last 50 years. The standard of care, ice storage, had not changed since the inception of organ transplant in the 1960s. Our team determined there was an opportunity 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 realized the first step in our vision, launching Paragonix SherpaPak® Cardiac Transport System for donor heart preservation, and to date have preserved over 1,000 donor hearts worldwide.
Medgadget: Can you tell me more about your organ preservation method while the organ is in transit? What are the innovations?
Dr. Anderson: 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 donor organs. Each system is slightly different based on specific user needs related to the organ type. For the Paragonix SherpaPak system, the innermost portion is a sterile pair of nested polycarbonate canisters which contain the heart and appropriate preservation solution, and allows for safe handling of the heart following recovery and monitoring of preservation solution temperature in real time. The canisters are surrounded by a series of proprietary phase change material pouches which help to keep the heart cool during storage and transport, and the 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. These proprietary phase change material pouches and device design are consistent across organs and the key to maintaining the 4-8°C organ environment.
Medgadget: What is the organ preservation solution you use? Do you recommend intracellular vs. extracellular solutions?
Dr. Anderson: Paragonix devices do not require a specific type of preservation solution. Paragonix devices are designed to use any FDA cleared preservation solution. This allows transplant centers and surgeons to utilize the preservation solution that works best for their process and patients.
Medgadget: What’s the longest time an organ in your system has been ex vivo while still remaining transplantable?
Dr. Anderson: Typical organ preservation times vary by organ type. For donor hearts, the most commonly cited literature recommends that ischemic time should be limited to 4 hours or less. The Paragonix SherpaPak is cleared to transport donor hearts up to 4 hours, and transportation exceeding 4 hours requires physician evaluation. To date, the longest total ischemic time for a case utilizing the Paragonix SherpaPak Cardiac Transport System was 7 hours and 8 minutes. Donor lungs typically have slightly longer ischemic times than donor hearts, usually between 2-8 hours. he Paragonix LUNGguard is cleared to transport donor lungs up to 8 hours, and cases longer than that similarly require physician evaluation. To date the longest ischemic time for a case utilizing the Paragonix LUNGguard Donor Lung Preservation System was 13 hours and 52 minutes.
Medgadget: What’s next for the company? How does it stack up against other companies such as OrganOx, Transmedics,etc ?
Dr. Anderson: Paragonix has FDA cleared and CE marked medical devices for the transport and preservation of donor hearts, lungs, pancreases, kidneys, and livers, all designed to improve donor organ quality and extend 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. The difference between the Paragonix SherpaPak and other organ preservation systems includes three main things: simplicity, connectivity and clinical data. Most other organ preservation devices are extremely complicated, labor intensive and require special personal or extensive training, while Paragonix’ devices are lightweight, user friendly, and a user can be trained in less than a few hours.
Second, The Paragonix devices can all be connected to our Paragonix mobile App, allowing medical professionals to help coordinate their case, monitor organ environment conditions real-time, and look at historical case data. Finally, unlike other systems on the market, thanks to our GUARDIAN Clinical Registry we have early published clinical results showing a reduction in organ complications when using the Paragonix SherapaPak as opposed to ice storage. These factors emphasize the difference with the Paragonix system – as opposed to these other technologies which are reserved for marginal edge cases, the Paragonix system is being utilized as standard of care for the vast majority of organ transports at institutions where it is adopted.