Clinical Evidence Shows Lower Costs and Better Outcomes in Heart Transplantation

CAMBRIDGE, Mass.–()–Paragonix Technologies, Inc., a leader in organ preservation technology and research, announced the release of a breakthrough organ transplant study in the Journal of the American Society for Artificial Internal Organs (ASAIO). This New Study Uses Real-World Clinical Data to Compare Two Preservation Methods: The Paragonix SherpaPak® Cardiac Transport System (PGNX) and the historic method of organ transport, cold storage (ICE). The study illustrates the favorable postoperative impact that advanced preservation technology can have on hospital costs and patient outcomes after heart transplantation.

The full study dataset was collected from August 2015 to November 2021 as part of the GUARDIAN-Heart Clinical Registry, analyzing a total of 174 propensity-matched patients (87 PGNX and 87 ICE) across 12 hospitals transplants across the United States. Study results indicate that patients whose hearts were transported using cold storage spent a significantly higher portion of their ICU days on mechanical circulatory support (MCS) compared to patients whose the donor heart was preserved with the Paragonix SherpaPak System (40.3% [ICE] against 10.8% [PGNX], p=<0.0001). After further comparison of preservation methods, transplants that used the Paragonix SherpaPak System showed a statistically significant reduction of $26,700 in average hospital costs, due to favorable clinical impacts affecting cost variables such as use of MCS, ICU stay and overall hospital stay.

The Paragonix SherpaPak Cardiac Transport System is an FDA cleared and CE marked device intended specifically for the transport, storage and monitoring of donor hearts traveling from donor to recipient. The analysis shows that when the advanced preservation device was used, recipients experienced a statistically significant reduction in the rate of severe primary graft dysfunction (PGD) (16.1% [ICE] against 5.7% [PGNX], p=0.03). The study also found a reduced need for ECMO and temporary VAD use when comparing the cohort of patients who used the Paragonix SherpaPak to the cohort dependent on cold ice storage.

“The adoption of innovative technology in the field of transplantation marks a turning point for an industry that has not changed for decades. In this study, patients in the SherpaPak cohort spent fewer days on mechanical circulatory support in the ICU, resulting in a statistically significant reduction in total cost per patient,” said Dr. David D’Alessandro, Surgical Director , Heart Transplantation and Ventricular Assist Devices, Harvard Medical School Faculty Member and US Principal Investigator of the GUARDIAN-Heart Study.

The study concluded that the use of the Paragonix SherpaPak system in the United States has potential benefits in terms of improved clinical outcomes and hospital costs over traditional methods of carrying coolers. “I believe it is essential to highlight the superior post-transplant outcomes associated with the reduced rate of severe primary graft dysfunction, as well as the use of mechanical circulatory support after cardiac intervention,” said Dr. Yasuhiro Shudo, Cardiothoracic Surgeon and Clinical Assistant Professor in the Department of Cardiothoracic Surgery, Stanford University School of Medicine. “In this study, the results indicate that the Paragonix SherpaPak can potentially improve post-transplant patient outcomes, resulting in reduced overall costs for hospitals.”

“Advanced organ preservation devices have become the new standard of patient care,” said Dr. Lisa Anderson, President and CEO of Paragonix Technologies. “Our technology continues to work in top hospitals and transplant centers across the country. The data shows that advanced preservation technology is a cost-effective and lower-risk solution than traditional transportation methods. »

About Paragonix Technologies

Paragonix Technologies is a leading provider of advanced organ preservation (AOP) devices that protect donor organs during the journey between donor and recipient patients. Our FDA cleared and CE marked devices incorporate clinically proven and medically reliable cold storage techniques that provide unprecedented physical and thermal protection of the organ in transit. Every Paragonix AOP device natively integrates with our new digital app, providing real-time organ tracking data and monitoring logistics for transplant teams looking for a secure, centralized solution.

GUARDIAN is a registered clinical study (NCT04141605) funded and administered by Paragonix Technologies. At the time of this analysis, GUARDIAN contained data from 12 sites on 490 patients. The register data is descriptive, not fed by statistics and not specified in advance. The information should be interpreted accordingly. In this analysis, cohorts of American adults were matched using statistical propensity matching to create cohorts of equal baseline characteristics (87 ice hauls and 87 Paragonix SherpaPak CTS hauls.

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