February 1, 2019 — Paragonix Technologies Inc. recently received clearance from the U.S. Food and Drug Administration (FDA) for a design enhancement allowing for the use of the Paragonix SherpaPak Cardiac Transport System (CTS) with small and pediatric donor hearts. Starting in Q1 2019, the system will now be shipped with heart connectors covering most aortic diameters, permitting the anchoring of various size hearts including small pediatric hearts to its proprietary suspension system for improved donor heart transport.
The system has been used by heart transplant centers in both the United States and in Europe. The device is currently marketed in the United Kingdom, France, Spain, Italy, Germany, Austria and Slovak Republic in Europe.
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, 10 percent of which are diagnosed with end-stage heart failure, 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. In 2017, over 2,000 donor hearts were transplanted in Europe.
The annual U.S. economic burden of treating heart failure exceeds $34.4 billion, over 50 percent of which is due to the cost of hospitalization. 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. In the U.S., around 30,000 people die annually from end-stage heart disease. As of February 2018, 3,990 patients in the U.S. were on the waiting list for a heart transplant and close to 4,000 patients in Europe are on the waiting list for a heart transplant every year. In 2017, 3,244 patients in the U.S. and over 2,000 European patients received a live-saving heart transplant. 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.
The Paragonix SherpaPak Cardiac Transport System (CTS) safeguards hearts during the journey from donor to recipient patient. The device incorporates cold preservation techniques in a novel suspension system to provide physical and thermal protection.
For more information: www.paragonixtechnologies.com