Paragonix leads the transport of organs with liver and heart milestones

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

The LIVERguard system provides a state-of-the-art highly controlled environment for hypothermic preservation of the liver, along with real-time digital tracking to safeguard a donor’s liver throughout the transplant journey from donation to transplant. Like all Paragonix systems, the LIVERguard system represents a major breakthrough in the use of commercial ice and refrigerators that have been the standard of care in organ transplantation for over 50 years.

© 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 largest heart transplant programs in the United States, as well as 45 more programs worldwide now rely on the Paragonix SherpaPak system to preserve and transport the hearts of critical donors to their recipient donors. The Paragonix SherpaPak CTS protects donor hearts with its rigid, sterile container and maintains a temperature between 4 and 8ºC, a range recommended by the International Heart and Lung Transplant Society as an optional condition for preserving the donor’s heart. Wireless connection to a simple application provides real-time monitoring of the organ environment and updates to the transplant equipment.

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

Alice Ferng, Medgadget: What are the main current issues with organ transport and how does Paragonix help bridge this gap?

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 over the past 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 for a more scientifically reproducible, measurable, and reliable solution for transporting an organ from a donor to a recipient. We set out to create a new standard for organ preservation and transportation that would provide the care and quality of handling in accordance with the transportation of such a valuable gift and improve patient outcomes worldwide. Paragonix has been developing these new donor organ preservation and transport systems since 2012. In 2018 we took the first step in our vision by launching the Paragonix SherpaPak® heart transport system for heart preservation. of donors, and to date we have preserved more than 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 of a series of interconnected systems that work together to provide a sterile environment of 4-8 ° C constantly 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 sterile pair of embedded polycarbonate containers that contain the heart and the proper storage solution, and allows safe handling of the heart after recovery and monitoring of the solution temperature. real-time conservation. The containers are surrounded by a series of patented phase change material bags that help keep the heart fresh during storage and transport, and the components in turn are housed in a working external wheeled transport device. to protect and insulate the inside contents as well as show the temperature of the solution. These patented phase change material bags and device design are consistent between the organs and the key to keeping the organ environment at 4-8 ° C.

Medgadget: What organ preservation solution do you use? Do you recommend intracellular or extracellular solutions?

Dr. Anderson: Paragonix devices do not require a specific type of storage 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 patients.

Medgadget: How long has an organ in your system been ex vivo while it can still be transplanted?

Dr. Anderson: Typical organ conservation times vary by organ type. For donor hearts, the most cited literature recommends that ischemic time should be limited to 4 hours or less. Paragonix SherpaPak is authorized to carry donor hearts for up to 4 hours, and transportation in excess of 4 hours requires a physician evaluation. So far, the longest total ischemic time for a case using the Paragonix SherpaPak cardiac transport system was 7 hours and 8 minutes. Donor lungs usually have slightly longer ischemic times than donor hearts, usually 2 to 8 hours. Paragonix LUNGguard is authorized to transport donor lungs for up to 8 hours, and longer cases also require a doctor’s evaluation. To date, the longest ischemic time for a case using the Paragonix LUNGguard donor lung preservation system was 13 hours and 52 minutes.

Medgadget: What about 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 transporting and preserving donor hearts, lungs, pancreas, kidneys, and liver, all designed to improve the quality of donor organs and extend the time of donor organ transport. . As we move forward, we are developing perfusion and pressure regulation technologies designed to improve the performance of our cardiac and pulmonary 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, require labor, and require special or extensive personal training, while Paragonix devices are lightweight, easy to use, and a user can train in less than ‘a few hours.

Second, all Paragonix devices can be connected to our Paragonix mobile app, allowing medical professionals to help 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 have published early clinical results that show a reduction in organ complications when using Paragonix SherapaPak instead of ice storage. These factors emphasize the difference with the Paragonix system: unlike these other technologies that are reserved for marginal cases, the Paragonix system is being used as a standard of care for the vast majority of organ transports in the United States. institutions where it is adopted.

Link: Paragonix Technologies Home Page …

Flashbacks: Donor SherpaPak and SherpaPerfusion heart transport refrigerators were cleaned in Europe; The Sherpa Pak transplant heart system is getting the green light in the United States;





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