CAMBRIDGE, Mass.--(BUSINESS WIRE)--Paragonix Technologies, Inc. today announced that the first series of pediatric donor hearts preserved and transported using Paragonix SherpaPak Cardiac Transport System occurred at University of Florida Health (UF Health) and Le Bonheur Children's Hospital (TN). Starting in Q1 2019, Paragonix SherpaPak™ CTS have been shipped with heart connectors covering most aortic diameters, permitting the anchoring of variously sized hearts, including small pediatric hearts, to its proprietary suspension system for improved donor heart transport.
“Optimal preservation of donor hearts is crucial. We have used Paragonix SherpaPak™ CTS to ensure protection of donor hearts transplanted at our Center, where we have transplanted three patients after using this type of preservation during transport,” said cardiothoracic surgeon Mark Bleiweis, MD, the William G. Lassiter Jr. and Aneice R. Lassiter Professor and director of the UF Health Congenital Heart Center at UF Health, the University of Florida’s academic health center. “We have now adopted Paragonix SherpaPak Cardiac Transport System for routine preservation of pediatric donor hearts.”
“Our Center’s first clinical use of Paragonix SherpaPak™ CTS to protect donor hearts occurred in October 2019. The device has been easily implemented into our procurement and transplant process. By having access to data records that profile the entire preservation interval we are able to improve our quality management in transplantation,” said Dr. Umar Boston, MD, director of pediatric heart transplant and heart failure at Le Bonheur Children’s Hospital in Memphis, Tennessee.
Paragonix SherpaPak™ CTS has been used by heart transplant centers in the United States and in Europe. The device is currently marketed in the United States, the United Kingdom, France, Spain, Italy, Germany, Austria, Sweden and the Slovak Republic in Europe.
“This first clinical series of pediatric donor hearts is an important milestone in making Paragonix SherpaPak™ CTS accessible for all donor populations, increasing the market reach of this important transplant product,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “We are thrilled with the clinical outcomes experienced by our customers following the use of Paragonix SherpaPak™ CTS.”
About University of Florida Health (UF Health)
University of Florida Health (UF Health) is a medical network associated with the University of Florida. It includes two academic hospitals – UF Health Shands Hospital in Gainesville and UF Health Jacksonville – and several other hospitals and facilities in North Florida. It used to be known as Shands Healthcare and UF&Shands. The network was named to the U.S. News & World Report's 2015 list of the nation's top 50 hospitals.
About Le Bonheur Children's Hospital
Le Bonheur Children's Hospital is a 255-bed, tertiary care children's hospital located in Downtown Memphis, Tennessee. Le Bonheur has more than 700 medical staff representing 40 pediatric specialties. Approximately 170 patients per day are admitted, mostly from Tennessee and nearby states but also from around the world, mainly due to its nationally recognized brain tumor program, affiliation with St. Jude Children's Research Hospital and for being the home of the Children's Foundation Research Center.
About the Cardiac Transplantation Market
Cardiac transplantation is considered the gold-standard therapy for patients in end-stage heart failure. With over 6.5 million Americans currently diagnosed with heart failure (HF)1, 10% of which are diagnosed with end-stage heart failure2, there is a persistent need to provide end-stage heart failure support to this expanding population. Estimates of the prevalence of symptomatic HF in the general European population are similar to those in the United States3. In 2017, over 2,000 donor hearts were transplanted in Europe4.
The annual US economic burden of treating heart failure exceeds $42.9 billion5, over 50% of which is due to the cost of hospitalization6. The financial demands associated with transplantation are considerable. The estimated first-year costs for a heart transplant are $997,700, and subsequent annual costs can easily exceed $30,0007. In the United States, around 30,000 people die annually from end-stage heart disease. As of February 2018, 3,990 patients in the United States were on the waiting list for a heart transplant8 and close to 4,000 patients in Europe are on the waiting list for a heart transplant every year9. In 2019, 3,551 patients in the United States10 and over 2,000 European patients received a live-saving heart transplant9. These data, however, only seem to represent the tip of the iceberg. Assuming that up to 157,000 people with end-stage heart failure are candidates for transplantation11, maximization of donor organ utilization has enormous potential in cardiac transplantation.
About Paragonix SherpaPak™ Cardiac Transport System
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.
About Paragonix Technologies, Inc.
Paragonix Technologies markets organ transportation devices that safeguard organs during the journey between donor and recipient patients. Our devices incorporate 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 transport device for heart transportation. Paragonix is also developing transport devices for the lungs and kidneys designed to improve donor organ quality and extending donor organ transport time.
3https://european-hospital.com/media/issue/161/issue.pdf
4http://www.transplant-observatory.org
5Circulation 2011;123(8):933-944
6Circulation 2007;115(5):e69-e171
7http://www.transplantliving.org
8http://optn.transplant.hrsa.gov
9https://ec.europa.eu/health/blood_tissues_organs/organs_en
10https://unos.org/data/transplant-trends/#transplants_by_organ_type+year+2017
11J Heart Lung Transplant 2011;30(10):1078-94
