BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. will present the Paragonix SherpaPak™ Cardiac Transport System product line at Medline Industries, Inc. Booths 45 and 46 during the 2018 American Association of Tissue Banks (AATB) Annual Meeting held in Dallas, TX, from 9 to 12 October, 2018. The Paragonix SherpaPak™ CTS1,2 is intended for the transport of donor hearts destined for transplantation into a recipient patient. The device combines innovative cooling technology with safe, consistent methods for cold ischemic storage and transport of donor organs. Real-time reporting of preservation temperature allows for continuous monitoring of transport conditions of the donor heart; at completion of the transport, these data are downloaded to Bluetooth-enabled devices for record keeping and sharing among the transplant team.
Bill Edelman, Chairman & CEO, for Paragonix commented, “We are excited to showcase the Paragonix Sherpa™ product portfolio to the tissue and organ procurement community. We are looking forward to discussing clinical use data collected for donor heart transports with the Paragonix SherpaPak™ Cardiac Transport System during the 2018 AATB Annual Meeting.”
About the AATB
The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific and educational organization. It is one of the only national tissue banking organizations in the United States, and its membership totals more than 120 accredited tissue banks and 2,100 individual members. These banks recover tissue from more than 39,000 donors and distribute in excess of 3.2 million allografts for more than 1.75 million tissue transplants performed annually in the U.S. The overwhelming majority of the human tissue distributed for these transplants comes from AATB-accredited tissue banks.
About the Paragonix SherpaPak™ and SherpaPerfusion™ Cardiac Transport System
Currently, the availability of cardiac transplantation is governed by the “ischemic time”, that being, the elapsed time from heart donation to recipient implantation. According to The International Society Of Heart and Lung Transplantation (“ISHLT”) guidelines3 for the care of heart transplant recipients, the projected ischemic time should not exceed 4 hours4,5, limiting the distance available to transport a donor heart. Paragonix SherpaPak™ Cardiac Transport System is fully disposable, eliminating problems associated with maintenance, device transport and contamination. The Paragonix SherpaPerfusion™Cardiac Transport System combines innovative oxygenated perfusion of organs and safe organ storage with the ultimate goal of extending ischemic time to 12 hours, significantly altering the transportation range of donor hearts.
About the Cardiac Transplantation Market
Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure6. With over 6.5 million Americans currently diagnosed with heart failure (HF)7, 10% of which are diagnosed with end-stage heart failure8, 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 States9. In 2017, over 2,000 donor hearts were transplanted in Europe10.
The annual US economic burden of treating heart failure exceeds $34.4 billion11, over 50% of which is due to the cost of hospitalization12. The financial demands associated with transplantation are considerable. The estimated first year costs for heart transplant are $997,700, and subsequent annual costs can easily exceed $30,00013. 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 are on the waiting list for a heart transplant14 and close to 4,000 patients in Europe are on the waiting list for a heart transplant every year15. In 2017, 3,244 patients in the United States16 and over 2,000 European patients received a live-saving heart transplant19. 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 transplantation17, maximization of donor organ utilization has enormous potential in cardiac transplantation.
About Paragonix Technologies, Inc.
Based in Massachusetts and founded in 2010, Paragonix Technologies Inc., is a privately held medical device company innovating the Paragonix SherpaPak™ and SherpaPerfusion™ Cardiac Transport System, a novel, single-use organ preservation device to improve donor organ quality. Paragonix has established a pipeline of donor organ transport devices that address the current donor organ shortage by maximizing donor organ utilization, improving donor organ quality and extending donor organ transport throughout the entire United States and Europe.
1 The SherpaPak™ Organ Transport product line is protected by patents, both issued and pending
2 The SherpaPak™ Organ Transport product line has received FDA 510(k) pre-market clearances and CE mark approval for both heart and kidney organ storage and transport
3 ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)
4 J Heart Lung Transplant 2001; 20(2):212.
5 J Am Coll Cardiol 2004; 43(9):1553-1561.
6 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.” http://about.datamonitor.com/media/archives/314
11 Circulation 2011;123(8):933-944
12 Circulation 2007;115(5)
17 J Heart Lung Transplant 2011;30:1078-94