Paragonix Technologies has initiated global post-market registry to asses clinical outcomes in patients receiving donor hearts transported with the firm’s SherpaPak cardiac transport system (CTS).
The global utilization and registry database for improved heart preservation (GUARDIAN) post-market registry will evaluate clinical outcomes when employing SherpaPak’s CTS for heart transplantations.
Paragonix will carry out the registry study at multiple transplant centers across the US and Europe.
The primary objectives of the post-market registry study are to assess short-term post-transplant outcomes (within the first 48 hours), intermediate term outcomes (within the first 30 days) and long-term outcomes (one-year survival).
The trial will also be used to analyze the impact of a variety of donor, recipient and transport-related parameters on patient outcomes, including donor clinical backgrounds, total ischemic times and recipient factors.
GUARDIAN trial principal investigator Dr Andreas Zuckermann said: “Temperature control is a critical aspect of the organ transportation process and with the Paragonix SherpaPak CTS we are able to remotely monitor the temperature of the organ through the journey to the recipient patient, thereby safeguarding the organ from cold injury.”
SherpaPak CTS protect hearts during the journey from donor to recipient patient. The device integrates cold preservation techniques in a novel suspension system to offer better physical and thermal protection.
Paragonix SherpaPak CTS is claimed to be the only commercially available FDA-cleared and CE-marked medical device for heart transportation.
According to the company, over 35 transplant centers across the world are trained to use the Paragonix SherpaPak CTS for donor heart transport.
At present, the system is available in the US, the UK, France, Spain, Italy, Germany, Austria, Sweden, Switzerland, Slovak Republic and The Netherlands.
Paragonix president and COO Dr Lisa Anderson said: “Clinical feedback regarding the Paragonix SherpaPak CTS has been extremely encouraging and we firmly believe we are on the path to improve the standard of care in how donor hearts are transported.
“An investment in a global registry reflects our commitment to patients as well as to the clinical community who have embraced the Paragonix SherpaPak CTS as a means of advancing donor heart preservation and transport.”