CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced clinical results presented during the Paragonix SherpaPak™ CTS 2019 International Heart Summit held during the International Society for Heart and Lung Transplantation (ISHLT) 2019 Annual Meeting in Orlando, FL. Five U.S. and European Centers shared clinical use experiences of the Paragonix SherpaPak™ Cardiac Transport System (CTS) for the preservation of donor hearts destined for heart transplantation.
Clinical experience on 49 donor heart preservation and transport cases using Paragonix SherpaPak™ CTS was reported to attendees. The clinical cases involved highly diverse donor backgrounds (ranging from standard to marginal donors) and transplant recipient backgrounds, as well as ischemic times beyond currently accepted clinical practice.
The largest collection of clinical use experience was presented by Dr. David D’Alessandro, Surgical Director, Heart Transplantation and Ventricular Assist Devices, at Massachusetts General Hospital (MGH) in Boston, Massachusetts. MGH has used the Paragonix SherpaPak™ CTS in 19 heart transplantations.
A study in the April issue of the Journal of Heart and Lung Transplantation recently reported on MGH’s use of the Paragonix SherpaPak™ CTS, concluding that organs transported using this system demonstrated normal perioperative function even including an organ with more than 5 hours of total ischemic time. In addition, the study found that this system may decrease cold injury during organ transportation and increase the safe interval of tolerable cold ischemia.
A complex clinical case series of marginal donor heart transports was reported by Dr. Andreas Zuckermann, Director of Cardiac Transplantation at the Vienna Cardiac Transplant Group at the Medical University of Vienna. Dr. Zuckermann described his clinical experience using the Paragonix SherpaPak™ CTS for hearts recovered from donors with complex recipient backgrounds and CPR times up to 90 minutes prior to recovery.
Cost-savings as result of reduced intensive care use (ICU) and hospital stays, as well as reduced primary graft dysfunction (PGD) and extracorporeal membrane oxygenation (ECMO), were reported by Dr. Jonathan Philpott, Cardiothoracic Surgeon at Sentara Healthcare in Norfolk, Virginia. According to Dr. Philpott, using the Paragonix SherpaPak™ CTS increased confidence in expanding geographic reach by 55% (>67 million potential donors, 10 additional US states) for donor heart procurements and also lead to substantial improvement in clinical outcomes as related to PGD.
Dr. Andrea Eixeres, Cardiothoracic Surgeon at University Hospital 12 de Octubre in Madrid, Spain, reported on the longest ever recorded ischemic time for a donated heart that required optimal preservation by Paragonix SherpaPak™ CTS. Successful heart transplantation of this donor heart with a total ischemic time of 420 minutes was one of a series of complex medical scenarios presented by Dr. Eixeres.
In another medical complex case series performed by Dr. Julia Dumfarth at Innsbruck Klinikum, Austria, data highlighted the ease-of-use, speed of heart recovery and standardization of donor heart procurements using Paragonix SherpaPak CTS.
“We are excited by the broad international clinical interest in the Paragonix SherpaPak™ CTS in support of advanced organ preservation in a cost-conscious health care environment,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “This clinical case series reinforced the strong market support we are seeing in adopting the Paragonix SherpaPak™ CTS in standard and complex heart transplant scenarios. The Paragonix SherpaPak™ CTS has been available commercially for less than one year and we are thrilled by the impressive clinical outcomes reported and by the impact our product has made among the transplant community.”
About the International Society for Heart and Lung Transplantation
The International Society for Heart and Lung Transplantation (ISHLT), established in 1981, is a professional organization committed to research and education in heart and lung disease and transplantation. It holds annual scientific meetings and publishes The Journal of Heart and Lung Transplantation. It also holds the largest registry of heart and lung transplant data in the world.
About the Paragonix SherpaPak™ Cardiac Transport System
The Paragonix SherpaPak™ Cardiac Transport System (CTS) safeguards hearts during the journey from donor to recipient patient. Our device incorporates clinically proven and medically trusted cold preservation techniques in a novel suspension system to provide unprecedented physical and thermal protection. Paragonix SherpaPak™ CTS is the only commercially available FDA cleared and CE marked medical device for heart transportation. More than 35 transplant centers throughout the world have been trained to use the system for donor heart transport. The Paragonix SherpaPak™ CTS is currently marketed in the United States, United Kingdom, France, Spain, Italy, Germany, Austria, Sweden, Switzerland, Slovak Republic and The Netherlands.