Paragonix Technologies, a medtech company based in Massachusetts, created the SherpaPak, an FDA organ transportation device that is intended to keep donor organs safe and viable on their journey to a transplant recipient. As the viability of a donor organ can mean life or death for the receiving patient, it makes sense to take exceptional care of it in transit.
The traditional method for organ transport is to simply pack it in ice in a beer cooler and hope for the best. This is arguably inadequate, as demonstrated by the recent GUARDIAN-Heart Registry multi-center study, which compared heart transplant recipients who received their new organ after traditional ice storage or transport in the SherpaPak. Those who received a heart out of a SherpaPak demonstrated a striking 8.7% increase in one year survival following the transplant.
The device allows clinical staff to suspend the organ in a preservation solution, which is then maintained at 4-8 degrees Celcius for optimal viability. The SherpaPak displays the internal temperature on an external display and also communicates with an app so that staff can be confident that nothing has gone wrong and the organ is still safe.
See a video about the SherpaPak below.
Medgadget had the opportunity to speak with Dr. Lisa Anderson, CEO, President and Co-Founder of Paragonix Technologies, about the technology.
Conn Hastings, Medgadget: Please give us an overview of the challenges inherent to transporting organs for transplant.
Lisa Anderson, Paragonix Technologies: Although transplantation research continues to expand at a rapid pace, there remains a lack of data regarding how transportation may affect a donor organ. Clinical studies have recently shown that donor organs are sensitive to the conditions in which they are preserved, prompting many clinicians to consider temperature control as one of the largest challenges along the transplant journey. The traditional method of organ preservation, ice storage, has not changed since the start of organ transplantation over fifty years ago. This static cold storage solution risks cellular injury to the organ, as temperatures near freezing can negatively impact clinical outcomes and have been linked to many complications related to donor organ viability and function.
The process of procuring a donor organ adds an additional layer of complexity to consider. Organ donors and patients in need of an organ are rarely co-located, which means that organs in general need to travel, often vast geographic distances. However, traveling greater distances often increases ischemic times (the amount of time that elapses when blood flow to an organ is interrupted) as well, which has historically been associated with an increase in post-transplant complications. In 2020, for example, Vanderbilt University Medical published an impressive clinical study that examined the increased distances traveled following changes to the adult donor heart allocation system. The study found that average ischemic times were increased nearly 40 minutes, and the rate of severe primary graft dysfunction (PGD) in the left ventricle, an important indicator of post-transplant complications, increased from 5.4% to 18.7%. A separate study from the University of Pittsburgh in 2021 “identified increased ischemic time as the most important risk factor,” and that “small incremental increases in ischemic time were associated with increased risk of PGD.”
Medgadget: What role does organ storage and transportation play in transplant patient outcomes?
Lisa Anderson: Organ preservation and transportation can have a significant impact on both short- and long-term patient outcomes. For this reason, Paragonix initiated patient enrollment in the GUARDIAN-Heart Registry in 2020 to study the effects of preservation on transplant outcomes. As of June 2022, we have partnered with clinical investigators at 17 transplant centers, who have enrolled over 1,200 patients to take part in this groundbreaking research. The registry collects and evaluates various parameters of clinical effectiveness in patients with transplanted donor hearts that were preserved and transported within the Paragonix SherpaPak™ Cardiac Transport System, in direct comparison to those transported in conventional ice storage. This research aims to help fulfill the current gap in data regarding the journey that donor hearts undergo.
Recently, at the 2022 ISHLT (International Society for Heart and Lung Transplantation) conference, Paragonix presented the US Multi Center 1-year Transplant Survival Analysis of the GUARDIAN Registry, which compiled and evaluated the 1-year outcomes of 569 adult patients who received heart transplants between October 2015 and January 2022. The analysis showed a statistically significant 72% reduction (p=0.005) in Severe Primary Graft Dysfunction (PGD) rates. Further, the study highlighted an 8.7% increase (p=0.03) in one-year survival when the Paragonix SherpaPak™ was utilized for donor heart preservation over ice transport. The positive results of the 1-year analysis demonstrates how advanced organ preservation technology can improve transplant patient outcomes, and we look forward to maintaining the GUARDIAN registry for further analysis.
In collaboration with transplant clinicians across the US, Paragonix also supports lung and liver data collection efforts for the LUNGguard and LIVERguard donor organ preservation devices: GUARDIAN-Lung and GUARDIAN-Liver registries.
Medgadget: What factors affect organ viability during storage and transport?
Lisa Anderson: In the past, transplant centers lacked an alternative to ice transportation. Experienced transplant teams were forced to make every effort to effectively and safely transport a life-saving donor organ in nothing more than a beverage cooler. Inconsistent and unmonitored ice conditions can potentially cause irreversible cellular damage and even graft failure to the donor organ – yet the procurement team would not be able to accurately gauge the temperature of the organ at any time during transport.
Now, Paragonix offers an advanced solution that enables transplant centers to standardize the transplant journey. By improving the method in which organs are transported, we aim to help preserve tissue and potentially avoid cellular harm. It is crucial to maintain a consistent, stable temperature above freezing temperatures throughout the entire journey, for the sake of preserving the donor organ effectively. However, it is just as important to have the ability to monitor the temperature at any point along the journey, for the sake of the transplant teams who do everything in their power to deliver these gifts of life in optimal condition.
Medgadget: What inspired you to create the SherpaPak?
Lisa Anderson: Paragonix was conceived in direct response to the lack of innovation in donor organ transport since the 1960’s. We determined that it was necessary to provide a universal preservation and storage device that was not only reliable, but also reproducible and measurable. 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, while improving patient outcomes worldwide. In 2018, we attained the first step in our vision by launching the Paragonix SherpaPak™ Cardiac Transport System for donor heart preservation. To date, we have preserved over 1,700 donor hearts worldwide.
Medgadget: Please give us an overview of the technology and how it works.
Lisa Anderson: The Paragonix SherpaPak™ CTS is made from a series of interconnected systems that provide a consistently cool, 4-8°C, sterile environment for the preservation and transport of the donor heart. The innermost container is a sterile pair of nested polycarbonate cylinders which protect the heart that is suspended in the appropriate preservation solution. This novel containment system allows for safe handling of the heart following recovery, and allows direct monitoring of the 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 at an optimal temperature during storage and transport. These components are housed inside a wheeled shipper device that protects and insulates the inner contents.
The device also features an external digital display on the front of the device so a procurement team can always monitor the solution’s temperature in real-time. Temperatures can also be monitored via the Paragonix app, available for download on any phone, tablet, or computer. The Paragonix companion app can pair with any Paragonix device, allowing real-time, centralized, and secure coordination between transplant teams. Team members can track the location and organ condition of every case, while maintaining a timeline of key events to accurately summarize the timing of a case.
This unique technology provides a consistent thermal environment and real-time data that gives surgeons the confidence to not only travel farther, thus expanding the donor pool, but also to help prevent potential tissue damage and irreversible cellular damage.
Medgadget: Please give us an overview of how the SherpaPak performed in the recent GUARDIAN-Heart Registry multi-center study.
Lisa Anderson: The U.S. multi-center 1-year Transplant Survival Analysis of the GUARDIAN Registry included 569 adult patients who received heart transplants between October 2015 and January 2022. The analysis showed a statistically significant 72% reduction (p=0.005) in Severe Primary Graft Dysfunction (PGD) rates, a type of severe heart injury that occurs within the first 72 hours of organ transplantation and is the most common cause of early mortality. The one-year survival rate in patients where traditional ice storage was used was 88.7%. In contrast, the one-year survival rate in patients where the SherpaPak was used was 96.4%. This groundbreaking study represented an 8.7% increase in one-year survival when using the SherpaPak for donor heart preservation as compared to traditional ice transportation.
Additionally, several other post-operative improvements were noted by the propensity matched study in favor of the SherpaPak cohort. There was a 38.5% reduction in all post-transplant MCS (mechanical circulatory support) and a 66.3% reduction in Post-transplant ECMO (extra corporeal membrane oxygenation) /VAD (ventricular assist device) (p=0.02). The study findings also showed a 59.7% reduction in newly placed IABP (intra-aortic balloon pump) (p=0.02).
We are working on new studies that evaluate specific subsets of patients, including an upcoming release that highlights a reduction of post-transplant complications utilizing the Paragonix SherpaPak when examining cases with extended ischemic times. Additionally, we aim to publish an upcoming report that surveys the cost-savings opportunities that the SherpaPak can provide, based on a reduction of total in-hospital costs. We expect to release these studies publicly before the end of the year.