Paragonix Leads Organ Transportation with Liver and Heart Milestones

Paragonix Technologies, a leading provider of donor organ preservation and transport systems, recently launched a new donor liver preservation system (LIVERguard) and a global liver registry.

The LIVERguard system provides a highly controlled, state-of-the-art environment for hypothermic liver preservation, along with real-time digital monitoring to protect a donor’s liver throughout the transplant process, from donation to transplantation. Like all Paragonix systems, the LIVERguard system represents a fundamental advance over the use of ice cubes and coolers that have been the standard of care in organ transplantation for more than 50 years.

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© Bryce Vickmark

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 heart transplant programs in the United States, as well as 45 other programs worldwide, now rely on 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 and sterile packaging and maintains a temperature between 4-8ºC, a range recommended by the International Society for Heart and Lung Transplantation as an optional condition for the preservation of the donor heart. Wireless connection to a simple app provides the transplant team with real-time organ environment monitoring and updates.

We had the opportunity to learn more from Paragonix Technologies CEO and Co-founder Dr. Lisa Anderson.

Alice Ferng, Medgadget: What are the biggest current problems with organ transport, and how does Paragonix help bridge that gap?

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Dr. Lisa Anderson, CEO and Co-Founder of Paragonix Technologies: Paragonix was conceived in response to our surprise at the lack of innovation in the preservation and transport of donor organs in the last 50 years. The standard of care, ice storage, had not changed since the beginning of organ transplantation in the 1960s. Our team determined that there was an opportunity to find a scientifically reproducible, measurable, and reliable solution to transporting a donor organ. to a receiver. We set out to create a new standard for the preservation and transport of organs that would provide the care and quality of handling commensurate with the transport of such a valuable gift and improve outcomes for patients around the world. Paragonix has been developing these new donor organ preservation and transport systems since 2012. In 2018, we took the first step in our vision, launching the Paragonix SherpaPak® cardiac transport system for donor heart preservation, and to date we have preserved more than 1,000 donor hearts around the world.

Medgadget: Can you tell me more about your method of preserving organs while the organ is in transit? What are the innovations?

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Dr. Anderson: Our devices are manufactured from a series of interconnected systems that work together to provide a sterile, constantly cool, 4-8 ° C environment for the preservation and transport of donor organs. Each system is slightly different depending on the specific needs of the user related to the type of organ. For the Paragonix SherpaPak system, the innermost part is a pair of nested polycarbonate containers that contain the core and the appropriate storage solution, and allow for safe handling of the heart after recovery and monitoring of the temperature of the storage solution. real-time conservation. The canisters are surrounded by a series of proprietary phase change material bags that help keep the heart cool during storage and transport, and the components are in turn housed in an external shipping device with wheels that works to protect and isolating the internal content as well as showing the temperature of the solution. These proprietary phase change material bags and device design are consistent across all organs and are the key to maintaining the 4-8 ° C organic environment.

Medgadget: What is the organ preservation solution you use? Do you recommend intracellular versus extracellular solutions?

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

Medgadget: What is the longest time that an organ in your system has been ex vivo without ceasing to be transplantable?

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Dr. Anderson: Typical organ preservation times vary depending on the type of organ. For donor hearts, the most frequently cited literature recommends that the ischemic time be limited to 4 hours or less. The Paragonix SherpaPak is authorized to transport donor hearts for up to 4 hours, and transport in excess of 4 hours requires a medical evaluation. 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 and 8 hours. The Paragonix LUNGguard is licensed to transport donor lungs for up to 8 hours, with longer cases requiring medical evaluation. To date, the longest ischemia time for a case using the Paragonix LUNGguard Donor Lung Preservation 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 approved and CE marked medical devices for the transport and preservation of donor hearts, lungs, pancreas, kidneys and livers, all designed to improve the quality of donor organs and extend the transport time of the donor. donor organ. Moving forward, we are developing perfusion and pressure regulation technologies designed to improve the performance of our heart and lung devices. The difference between 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 or extensive personal training, while Paragonix devices are lightweight, easy to use, and the user can be trained in less than a few few hours.

Second, all Paragonix devices can be connected to our Paragonix mobile app, allowing medical professionals to help coordinate your case, monitor organ environmental conditions in real time, and view historical case data. Finally, unlike other systems on the market, thanks to our GUARDIAN Clinical Registry, we have published early clinical results showing a reduction in organic complications when using Paragonix SherapaPak instead of ice storage. These factors emphasize the difference to the Paragonix system: unlike these other technologies that are reserved for extreme marginal cases, the Paragonix system is used as the standard of care for the vast majority of organ transports in institutions where it is adopted.

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Link: Paragonix Technologies Home Page …

Flashbacks: SherpaPak and SherpaPerfusion Donor Heart Transport Coolers approved in Europe; Sherpa Pak Transplant Cardiac Transport System Gets Green Light in US

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