Health

Paragonix leads organ transports with milestones for the liver and heart

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 protect a donor liver throughout the transplant path from donation to transplant. Like all Paragonix systems, the LIVERguard system represents a fundamental advancement over the use of ice and standard coolers that have been the standard in organ transplantation for over 50 years.

© Bryce Vickmark

Recently, on November 16, 2021, Paragonix launched its flagship product, the Paragonix SherpaPak Heart Transport System (CTS).

Four of the five largest heart transplant programs in the United States and 45 other programs worldwide now rely on the Paragonix SherpaPak system to receive critical donor hearts and move them to their recipient donors. The Paragonix SherpaPak CTS protects donor hearts with its rigid, sterile container and maintains a temperature between 4-8 ° C, an area recommended by the International Society of Heart and Lung Transplantation as an optional condition for preserving the donor heart. The wireless connection to a simple app provides the transplant team with tracking of the organ environment and real-time updates.

We had the opportunity to hear more from the CEO and Co-Founder of Paragonix Technologies, Dr. Lisa Anderson, to find out.

Alice Ferng, Medgadget: What are the biggest problems with organ transport today and how is Paragonix helping to close this gap?

DR. Lisa Anderson, CEO & Co-Founder of Paragonix Technologies: Paragonix was developed in response to our surprise at the lack of innovation in the preservation and transportation of donor organs over the past 50 years. The standard of care, ice storage, hadn’t changed since organ transplantation was first introduced in the 1960s. Our team determined that there was a way for a more scientifically reproducible, measurable, and reliable solution for moving an organ from a donor to a recipient. Our goal is to create a new standard for organ preservation and transport that provides the care and quality of handling appropriate to transport such a precious gift, and improve patient outcomes around the world. Paragonix has been developing these innovative donor organ preservation and transport systems since 2012. In 2018, we realized the first step in our vision with the introduction of the Paragonix SherpaPak® Cardiac Transport System for donor heart preservation and to date we have preserved over 1,000 donor hearts worldwide.

Medgadget: Can you tell me more about your method of organ preservation while the organ is being transported? What are the new features?

Dr. Anderson: Our devices consist of a number of interconnected systems that work together to provide a consistently cool, sterile environment of 4–8 ° C for the preservation and transportation of donor organs. Each system is slightly different based on specific user needs regarding the organ type. In the Paragonix SherpaPak System, the innermost portion consists of a sterile pair of nested polycarbonate containers that contain the heart and the appropriate preservation solution and allow safe handling of the heart after recovery and real-time monitoring of the preservation solution temperature. The canisters are surrounded by a series of proprietary phase change material bags that keep the heart cool during storage and transportation, and the components are in turn housed in a wheeled outer transport device that protects the internal contents and isolates them from displaying the solution temperature. These proprietary phase change material bags and device design are common to all organs and are key to maintaining the organ environment at 4-8 ° C.

Medgadget: Which Organ Preservation Solution Do You Use? Do you recommend intracellular vs. extracellular solutions?

Dr. Anderson: Paragonix devices do not require a special type of preservation solution. Paragonix devices are designed to use any FDA approved preservation solution. This enables transplant centers and surgeons to use the preservation solution that is best for their process and their patients.

Medgadget: How long has an organ been in your system ex vivo while it was still transplantable?

Dr. Anderson: The typical preservation times for organs vary depending on the type of organ. For donor hearts, the most widely cited literature recommends limiting the ischemic time to 4 hours or less. The Paragonix SherpaPak is approved for the transport of donor hearts for up to 4 hours, and transport for more than 4 hours requires a medical examination. To date, the longest total ischemic time for a case using 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. The Paragonix LUNGguard is approved for transporting donor lungs for up to 8 hours, and longer cases also require a medical examination. To date, the longest ischemic time for a case using the Paragonix LUNGguard Donor Lung Support System was 13 hours and 52 minutes.

Medgadget: What’s Next for the Company? How does it compare to other companies like OrganOx, Transmedics, etc.?

Dr. Anderson: Paragonix has FDA cleared and CE marked medical devices for the transportation and preservation of donor hearts, lungs, pancreas, kidneys and livers, all designed to improve the quality of donor organs and extend donor organ transit time. In the future, we will develop perfusion and pressure regulation technologies designed to improve the performance of our heart and lung devices. The difference between the Paragonix SherpaPak and other organ preservation systems is three main features: simplicity, connectivity and clinical data. Most other organ preservation devices are extremely complicated, labor intensive, and require specialized personal or extensive training, while Paragonix devices are lightweight, easy to use, 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, so clinicians can coordinate their case, monitor organ environment conditions in real time, and view historical case data. Finally, unlike other systems on the market, thanks to our GUARDIAN Clinical Registry, we published early clinical results that demonstrate a reduction in organ complications when using the Paragonix SherapaPak as opposed to ice storage. These factors underline the difference to the Paragonix system – unlike these other technologies, which are reserved for marginal edge cases, the Paragonix system is used as the standard supply for the vast majority of organ transports in institutions in which it is used.

Shortcut: Paragonix Technologies homepage …

Flashbacks: SherpaPak and SherpaPerfusion dispensers for cardiac transport coolers released in Europe; Sherpa Pak Transplantation Heart Transport System receives the green light for the US;

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