3,000
Participants
Start Date
February 14, 2020
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2029
SherpaPak Cardiac Transport System
"The Paragonix SherpaPak Cardiac Transport System (SherpaPak CTS) is an ultraportable hypothermic preservation and transport system intended for use with donor hearts. The device is a legally marketed, FDA cleared medical device in the United States and CE Marked medical device in the European Union.~The SherpaPak CTS consists of multiple components: 1) outer transport shipper which contains within various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly which provides a rigid barrier enclosure in which the heart is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts, 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart is stored during transport, and 4) four size heart connectors designed to accommodate various size aortic stem diameters by which donor hearts are attached."
Allgemeines Krankenhaus Wien, Vienna
University of Graz, Graz
NewYork-Presbyterian Columbia University Irving Medical Center, New York
Pennslyvania State University, State College
Medstar Washington Hospital, Washington D.C.
Sentara Healthcare, Norfolk
Duke University, Durham
Mayo Clinic, Jacksonville
University of Florida Health Shands Hospital, Gainesville
AdventHealth Orlando, Orlando
Le Bonheur Children's Hospital, Memphis
Cincinnati Children's Hospital, Cincinnati
Lutheran Hospital, Fort Wayne
Spectrum Health, Grand Rapids
Kansas University Medical Center, Lawrence
Baylor University Medical Center, Dallas
Stanford University, Stanford
Tufts University Medical Center, Boston
Massachusetts General Hospital, Boston
Hospital Universitario 12 de Octubre, Madrid
Hospital Clínico Universitario de Valladolid, Valladolid
Manchester University, Manchester
Lead Sponsor
Paragonix Technologies
INDUSTRY