Paragonix Reports First Successful Use of its SherpaPak Cardiac Transport System

The first series of pediatric donor hearts preserved and transported using Paragonix SherpaPak Cardiac Transport System from Paragonix Technologies Inc. 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, M.D., 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, M.D., director of pediatric heart transplant and heart failure at Le Bonheur Children’s Hospital in Memphis.
 
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.”
 
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 percent of which are diagnosed with end-stage heart failure,² 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 States.³ In 2017, over 2,000 donor hearts were transplanted in Europe.⁴
 
The annual U.S. economic burden of treating heart failure exceeds $42.9 billion,⁵ over 50 percent of which is due to the cost of hospitalization.⁶ 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 $30,000.⁷ 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 year.⁹ In 2019, 3,551 patients in the United States¹⁰ and over 2,000 European patients received a live-saving heart transplant.⁹ 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 transplantation,¹¹ maximization of donor organ utilization has enormous potential in cardiac transplantation.
 
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 U.S. Food and Drug Administration-cleared and CE-marked medical device for heart transportation.

References 
¹ http://newsroom.heart.org/news/latest-statistics-show-heart-failure-on-the-rise;-cardiovascular-diseases-remain-leading-killer
² http://www.heart.org/HEARTORG/Conditions/HeartFailure/LivingWithHeartFailureAndAdvancedHF/Advanced-Heart-Failure_UCM_441925_Article.jsp#.WosY7GNLPjI
³ https://european-hospital.com/media/issue/161/issue.pdf
⁴ http://www.transplant-observatory.org
⁵ Circulation 2011;123(8):933-944
⁶ Circulation 2007;115(5):e69-e171
⁷ http://www.transplantliving.org
⁸ http://optn.transplant.hrsa.gov
⁹ https://ec.europa.eu/health/blood_tissues_organs/organs_en
¹⁰ https://unos.org/data/transplant-trends/#transplants_by_organ_type+year+2017
¹¹ J Heart Lung Transplant 2011;30(10):1078-94