Paragonix SherpaPak™ Cardiac Transport System is the only FDA cleared and CE marked device that safeguards hearts between donor and recipient patients
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced AdventHealth (Orlando, Florida) has adopted its Paragonix SherpaPak™ Cardiac Transport System (CTS) for the preservation of donor hearts for transplantation. A recent application of this innovative technology permitted the transport and preservation of a donor heart from nearly 1,000 miles away from AdventHealth’s transplant center in Orlando, Florida.
“As a successful high volume advanced heart failure and heart transplant center in Florida, our heart procurement teams are working around the clock to ensure our recipients on the waitlist receive a donor heart. We are thrilled about the addition of Paragonix SherpaPak™ Cardiac Transport System as a tool to provide best-in-class care of our transplant patients. Optimal preservation and quality management of the donor heart during transport from donor to recipient is paramount,” said cardiothoracic surgeon Dr. Scott Silvestry, Surgical Director of Thoracic Surgery at AdventHealth Transplant Institute in Orlando, Florida. “Furthermore, procuring a donor heart from extreme geographic distances requires utmost control of the process and monitoring of the preservation conditions of the heart in transport. Paragonix SherpaPak™ has made a typically uncontrolled process a highly controlled procedure with a permanent data record.”
“Our mission at OurLegacy is to maximize donor organ utilization and to provide the best quality donor organs to the transplant programs that we serve. We are excited about partnering with Dr. Silvestry and Barry Friedman RN, the Executive Director from AdventHealth Transplant Institute, to implement new standard-of-care technologies like Paragonix SherpaPak™ CTS,” said Virginia McBride, Director, OurLegacy OPO.
Paragonix SherpaPak™ CTS has been adopted or is being evaluated by over 20 major heart transplant centers in the United States and by over 15 European transplant centers. The device is currently marketed in the United States, the United Kingdom, Ireland, Switzerland, France, Spain, Italy, Germany, Austria, Sweden and the Slovak Republic in Europe.
“Patients on the waitlist for a donor heart face so many medical uncertainties. The preservation of the donor heart they are waiting for should not be one of them. We are thrilled to contribute a key tool to the transplant teams in giving their transplant recipients every possible advantage on their journey of receiving a donor heart,” said Bill Edelman, Chairman and CEO of Paragonix Technologies. “Elimination of preservation issues from the previously used method—like submerging transplant organs in an ice chest without any control over temperature or the inability to monitor—is translating into excellent clinical outcomes at our customers’ transplant programs.”
About the Cardiac Transplantation Market
Cardiac transplantation is considered the gold-standard therapy for patients in end-stage heart failure1. With over 6.5 million Americans currently diagnosed with heart failure (HF) 2, 10% of which are diagnosed with end-stage heart failure3, 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 States4. In 2017, over 2,000 donor hearts were transplanted in Europe5.
The annual US economic burden of treating heart failure exceeds $42.9 billion6, over 50% of which is due to the cost of hospitalization7. 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 $30,0008. 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 transplant9 and close to 4,000 patients in Europe are on the waiting list for a heart transplant every year10. In 2019, 3,551 patients in the United States11 and over 2,000 European patients received a life-saving heart transplant. This data, however, only seems to represent the tip of the iceberg. Assuming that up to 157,000 people with end-stage heart failure are candidates for transplantation12, maximization of donor organ utilization has enormous potential in cardiac transplantation.
About AdventHealth
With a sacred mission of Extending the Healing Ministry of Christ, AdventHealth is a connected system of care for every stage of life and health. More than 80,000 skilled and compassionate caregivers in physician practices, hospitals, outpatient clinics, skilled nursing facilities, home health agencies and hospice centers provide individualized, wholistic care. A shared vision, common values, focus on whole-person health and commitment to making communities healthier unify the system’s nearly 50 hospital campuses and hundreds of care sites in diverse markets throughout almost a dozen states. For more information about AdventHealth, visit AdventHealth.com, or Facebook.com/AdventHealth.
About OurLegacy
OurLegacy employs 56 skilled professionals, including individuals who guide families sensitively through end-of-life decisions, as well as clinical experts and specialists who work around the clock to help as many people as possible. Their work is supported by hospitals, transplant centers, medical examiners and funeral homes; schools, houses of worship, the DMV and other community pillars; and volunteer ambassadors including donor family members, living donors and transplant recipients.
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.
References
1 Datamonitor senior cardiovascular analyst Dr. Sergey Ishin. “Cardiac transplantation continues to be the gold standard for the treatment of end-stage heart failure. However, the number of potential transplants far exceeds the number of donors.” https://european-hospital.com/media/issue/161/issue.pdf
2http://newsroom.heart.org/news/latest-statistics-show-heart-failure-on-the-rise;-cardiovascular-diseases-remain-leading-killer
3http://www.heart.org/HEARTORG/Conditions/HeartFailure/LivingWithHeartFailureAndAdvancedHF/Advanced-Heart-Failure_UCM_441925_Article.jsp#.WosY7GNLPjI
4https://european-hospital.com/media/issue/161/issue.pdf
5http://www.transplant-observatory.org
6Circulation 2011;123(8):933-944
7Circulation 2007;115(5):e69-e171
8http://www.transplantliving.org
9http://optn.transplant.hrsa.gov
10https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/ev_20141126_factsfigures_en.pdf
11https://unos.org/data/transplant-trends/#transplants_by_organ_type+year+2017
12J Heart Lung Transplant 2011;30(10):1078-94