Paragonix Technologies Receives European Approval for SherpaPak, SherpaPerfusion Systems

Paragonix Technologies Inc. has received European approval for Paragonix SherpaPak Cardiac Transport System^1,2 and SherpaPerfusion Cardiac Transport System^3,4 for application of a CE mark following review of a Technical File submission by The British Standards Institution (BSI). Paragonix was issued a CE Certificate by BSI for the design and manufacture of organ transportation devices for hearts and kidneys. This includes the Paragonix SherpaPak and SherpaPerfusion family of products.

The SherpaPak Cardiac Transport System consists of a single-use, disposable device for the hypothermic static preservation and transport of donor hearts. The SherpaPerfusion Cardiac Transport System consists of a single-use, disposable device for hypothermic oxygenated perfusion preservation and transport of donor hearts.
 
In 2017, over 2,000 donor hearts were transplanted in Europe.⁵ In spite of significant advances in surgical technique, tissue typing, and immunosuppression, maintenance of organ quality during transport has largely been overlooked. The current standard of care for donor heart preservation and transportation involves placing a heart in a series of fluid-filled sterile bags that are placed on crushed ice contained within a conventional ice chest. Unfortunately, this leads to temperatures below 2oC which significantly increase the risk of cold injury and frostbite. Additionally, the current standard of care for donor heart transport limits the time an organ can be outside the body. To overcome these limitations and ensure optimal organ health following transportation, Paragonix Technologies has developed the Paragonix Sherpa platform of donor heart preservation devices as a powerful new technology ensuring superior organ quality during transport.
 
“I am excited about the European availability of Paragonix’s two innovative donor heart preservation devices,” said Dr. Steven Tsui, director of Transplantation & Mechanical Circulatory Support and consultant surgeon at the Royal Papworth Hospital in the United Kingdom. “I believe that the SherpaPak Cardiac Transport System addresses the shortcomings of current cold storage by improving temperature maintenance and monitoring of the donor heart during transport. As a heart transplant surgeon with over a decade’s experience of ex-vivo donor heart perfusion, I also welcome the addition of SherpaPerfusion Cardiac Transport System to the clinical community, utilizing oxygenated hypothermic perfusion for improved donor heart quality. I look forward to both products entering the clinic.”
 
“Having followed the extensive research and product development activities at Paragonix Technologies over the past few years, I am impressed by the intuitive designs of both SherpaPak and SherpaPerfusion Cardiac Transport Systems. They directly address all relevant issues of improving donor heart preservation at hypothermia.” said Dr. Andreas Zuckermann, director of the Cardiac Transplantation Program at the University of Vienna, Austria. “We look forward to incorporating both donor heart preservation systems at our transplant center.”
 
“We are thrilled to have reached this milestone and anticipate significant clinical interest for both SherpaPak and SherpaPerfusion Cardiac Transport Systems. Following our commercial launch of SherpaPak in the United States, we look forward to introducing our novel donor heart preservation devices to transplant centers across Europe,” said Dr. Lisa Anderson, president and chief operating officer of Paragonix.
 
Currently, the availability of heart and lung 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”) guidelines⁶ for the care of heart transplant recipients, the projected ischemic time should not exceed four hours,^7,8 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.
 
Cardiac transplantation is considered the gold standard therapy for patients in end-stage heart failure.⁹ With over 6.5 million Americans currently diagnosed with heart failure (HF),¹⁰ 10 percent of which are diagnosed with end-stage heart failure,¹¹ 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.¹² The annual U.S. economic burden of treating heart failure exceeds $34.4 billion,¹³ over 50 percent of which is due to the cost of hospitalization.¹⁴ 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 $30,000.¹⁵ 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 transplant¹⁶ and close to 4,000 patients in Europe are on the waiting list for a heart transplant every year.¹⁷ In 2017, 3,244 patients in the United States¹⁸ and over 2,000 European patients received a live-saving heart transplant.¹⁹ 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, maximization of donor organ utilization has enormous potential in cardiac transplantation.
 
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.

References
1. The SherpaPak™ Cardiac Transport System is protected by patents, both issued and pending.
2. The SherpaPak™ Cardiac Transport System has received FDA 510(k) pre-market clearance for heart storage and transport.
3. The SherpaPerfusion™ Cardiac Transport System is protected by patents, both issued and pending.
4. The SherpaPerfusion™ Cardiac Transport System is not approved for sale in the United States at this time.
5. http://www.transplant-observatory.org
6. ISHLT Guidelines for the Care of Heart Transplant Recipients, Task Force 1: Peri-operative Care of the Heart Transplant Recipient (Aug. 4, 2010)
7. J Heart Lung Transplant 2001; 20(2):212.
8.J Am Coll Cardiol 2004; 43(9):1553-1561.
9. 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
10. http://newsroom.heart.org/news/latest-statistics-show-heart-failure-on-the-rise;-cardiovascular-diseases-remain-leading-killer
11. http://www.heart.org/HEARTORG/Conditions/HeartFailure/LivingWithHeartFailureAndAdvancedHF/Advanced-Heart-Failure_UCM_441925_Article.jsp#.WosY7GNLPjI
12. http://about.datamonitor.com/media/archives/314
13. Circulation 2011;123(8):933-944
14. Circulation 2007;115(5)
15. http://www.transplantliving.org
16. http://optn.transplant.hrsa.gov
17. https://ec.europa.eu/health/sites/health/files/blood_tissues_organs/docs/ev_20141126_factsfigures_en.pdf
18. https://unos.org/data/transplant-trends/#transplants_by_organ_type+year+2017
19. J Heart Lung Transplant 2011;30:1078-94